project management sop clinical research

Standard Operating Procedures for Clinical Trials (SOPs)

The Clinical Trials Unit at Kilimanjaro Christian Medical Center has prepared numerous Standard Operating Procedures (SOPs) for clinical trials that meet NIH requirements. DGHI is pleased to share these documents with others who are working in resource-limited locations. Although most of these SOPs were developed for AIDS clinical trials, many of these documents can be modified and extrapolated to meet your specific project needs.

SOPs are available in the areas of:

Administrative   ( Download PDF Bundle - 93KB Zip File )

• Procurement
• Vehicle use

Clinical   ( Download PDF Bundle - 1.6MB Zip File )

• Clinic Flow policies & procedures
• Clinical research management plan
• Protocol implementation
• Source documentation
• Essential documents
• Office charts
• Study visits and missed visits
• Study medications
• Toxicity management
• Subject recruitment
• Subject logs and codes
• Transportation reimbursement
• Ethics committee submission checklist
• New protocol evaluation survey
• Orientation manual
• Quality management plan
• Research coordinator checklist
• Study nurse checklist
• Monitoring visits
• Regulatory affairs
• Site assessment
• Site responsibility
• Patient and study identification numbers
• Safety reports
• Training record
• Venipuncture

Data Management  ( Download PDF Bundle - 92KB Zip File )

• Case report forms (CRF) completion
• CRF scanning
• Data security
• Definitions
• International communications
• Query resolution
• Power failure during data entry
• CRF quality assurance
• Table of contents

Laboratory  ( Download PDF Bundle - 2.9MB Zip File )

• Over 60 SOPs regarding laboratory equipment, supplies, and tests

Pharmacy  ( Download PDF Bundle - 316KB Zip File )

• Infant prescriptions
• Pharmacy plan
• Study accountability records
• Post trial ARV access
• Refrigerator temperature logs
• Room temperature logs
• Site pharmacist checklist
• Policies and Procedures
• Disposal of unfit pharmaceuticals
• Disposal of unfit products
• Importing study products
• Prescription numbering
• Drug transfer form

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Downloadable Templates and Tools for Clinical Research

Welcome to global health trials' tools and templates library. please note that this page has been updated for 2015 following a quality check and review of the templates, and many new ones have been added. please click on the orange text to download each template., the templates below have been shared by other groups, and are free to use and adapt for your researchstudies. please ensure that you read and adapt them carefully for your own setting, and that you reference global health trials and the global health network when you use them. to share your own templates and sops, or comment on these, please email [email protected]. we look forward to hearing from you.

These templates and tools are ordered by category, so please scroll down to find what you need.

To share your own templates and SOPs, or comment on these, please email [email protected]. We look forward to hearing from you!

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This is Degena Bahrey Tadesse from Tigray, Ethiopia. I am new for this web I am assistant professor in Adult Health Nursing Could you share me the sample/templet research proposal for Global Research Nurses Pump-priming Grants 2023: Research Project Award

I have learned lot..Thanks..

i was wondering why there is no SOP on laboratory procedures ?

Hi, Can you provide me the SOP for electronic signatures in Clinical trial

Do you have an "SOP for Telephonic site selection visit". Kindly Share on my registered mail ID

Thank you for sharing the resources. It is very kind of you.

Hi These tolls are very useful! Thank you

Do you have a task and responsability matrix template for clinical trial managment ? Best

I am very much happy to find myself here as a clinician

Dear Getrude

We have a free 14-module course on research ethics on our training centre; you'll receive a certificate if you complete all the modules and quizzes. You can take it in your own time. Just visit 'Training centre' in the tabs above, then 'short courses'.

Kind regards The Editorial Team

need modules on free online gcp course on research ethics

Estimados: me parece excelente el aporte que han hecho dado que aporta. por un lado a mejorar la transparencia del trabajo como a facilitar el seguimiento y supervisión de los mismos. Muchas gracias por ello

We also have an up to date list of global health events available here: https://globalhealthtrials.tghn.org/community/training-events/

Dear Nazish

Thank you, I am glad you found the seminars and the training courses useful. We list many training events (all relevant to Global Health, and as many of them as possible are either free or subsidised) on the 'community' web pages above. Keep an eye on those for events and activities which you can get involved with. Also, if you post an 'introduction' on the introduction group stating where you are from and your research interests, we can keep you updated of relevant local events.

Thanks so much. These are very helpful seminars. Please let me know any other websites/links that provide free or inexpensive lectures on clinical Research. Appreciate your help.

Hi Nazish, and welcome to the Network. The items here are downloadable templates for you to use; it sounds like you may be seeking lectures and eLearning courses? If so - no problem! You can find free seminars with sound and slides here: https://globalhealthtrainingcentre.tghn.org/webinars/ , and you can find free, certified eLearning courses here: https://globalhealthtrials.tghn.org/elearning . Certificates are awarded for the eLearning courses for those scoring over 80% in the quiz at the end of each course. If you need anything else, do ask! Kind regards The Editorial Team

Hi, I am new to this website and also to the Clinical Research Industry for that matter I only am able to see the PDF of these courses, just wanted to know are these audio lectures and also happen to have audio clips that go with the pdf?

This site is impeccable and very useful for my job!!!!

Thank you for your kind comments.

Fantastic resources

I am delighted you found this website. I earlier introduced it to you because of your prolific interest in health care information and resource sharing....

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Clinical research project management: back to basics.

Clinical trials require care and precision regarding planning, coordination, and collaboration. The stakes are high, with participants’ health and well-being and significant investments of both time and money on the line. That’s why clinical research project managers are necessary – to ensure coordinated and collaborative efforts between numerous departments, teams, and vendors that adhere to the study protocol as well as regulatory and ethical standards. In this article, we will take an in-depth look at the basics of clinical research project management.

What is project management in clinical research?

Clinical trials involve several complex, dynamic parts with different boundaries/areas of responsibility, and personnel with specific skill sets and qualifications. As a consequence, successful clinical trials require organizers who are adept at project management.

Clinical trials can be thought of as large-scale, complex projects with multiple milestones and parallel workstreams, including:

• Study and protocol design
• Study startup
• Site activation
• Recruitment
• Documentation (promotional material, informed consent forms, case report forms, protocol documents, surveys, etc.)
• IRB and IEC approval
• Site management
• Investigational product distribution and management of study materials
• Laboratories (analyses, lab tests, imaging, etc.)
• Reporting and regulatory affairs

Why is project management in clinical research important?

Clinical research involves multiple stakeholders. Project management can essentially be thought of as monitoring progress and keeping everyone involved on the same page. Project management is critical for the success of a clinical trial; it helps the different teams stay on schedule, adhere to protocol, and communicate amongst one another, as well as meet the trial objectives/targets, maintain quality standards, stay within budget, and follow regulatory requirements.

The following are three major reasons why project management in clinical research is important:

Timeline management

Project management ensures the delivery of clinical trial objectives and sub-objectives within the allocated time and budget. This is important because nearly 85% of all clinical trials experience delays. [1] Project management techniques can allow investigators to plan ahead if it looks like a deadline is not going to be met, so they can reallocate resources and priorities to accelerate the process, or otherwise notify teams responsible for tasks that would be affected by the resultant delay and adjust the timelines.

Streamline and facilitate communications

It is important for the various stakeholders involved in a clinical trial to be on the same page. Keeping all of these actors updated and facilitating communication amongst them is another task of the project management team. Lack of communication in clinical trials can have negative consequences on the quality of research. [2] An efficient project manager or management team can streamline communication and collaboration between multiple teams and departments, further increasing the transparency of the individual but interdependent operations.

Quality control (QC)

Quality control is another important aspect of clinical research project management. Quality standards are often stringent, but this is designed to protect the safety of participants and the general population. Clinical trials that fail to adhere to or meet quality standards will not be considered to have provided sufficient evidence on the effectiveness and/or safety of an investigational drug. Researchers and investigators tend to be under a lot of pressure as trials are often on tight budgets and timelines, but it is important that quality not be sacrificed in order to meet other objectives.

Project management helps sponsors/investigators manage all objectives and sub-tasks in a clinical trial while still prioritizing adherence to quality and regulatory standards. Part of the task of the project management team may even be to define internal quality standards for specific tasks, objectives, and/or teams.

What does a clinical research project manager do?

A clinical research project manager coordinates with other departments, teams, and personnel involved in the clinical trial to ensure the organized completion of clearly defined tasks. They also manage external vendors such as central laboratories or technology providers. Project managers will monitor the progress of all tasks and objectives to keep the study on track according to its protocol, including timeline and budget, and also communicate with stakeholders such as the sponsor to keep them up to date.

What is the clinical research project manager responsible for?

The responsibilities of a clinical research project manager depend on the specifics of the trial and its complexity, but they generally include the following:

• Planning : This includes general planning of the trial, including the internal organization between departments/teams, how tasks should be executed in order to comply with regulations, how many and which sites to involve, whether external tools/solutions need to be contracted, etc.
• Budgeting : Making sure that the study’s resources are allocated appropriately to the different teams/tasks, within the overall study budget, also providing room for unexpected costs or delays.
• Vendor identification/selection : Negotiation with vendors, technology providers, and suppliers.
• Scheduling : Scheduling the objectives/sub-tasks of the clinical trial and monitoring activities to make sure they are completed on time.
• Liaising : Acting as a central point of contact for members of the project team and sponsors.
• Task delegation : Assigning tasks to team members and updating them about their responsibilities, as well as deadlines and expectations.

What are the key topics included in a clinical research project plan?

The project manager may organize all of the above-mentioned tasks and responsibilities into a document or repository referred to as a clinical research project plan. This plan would formally outline standard protocols for aspects of the clinical research project management, such as:

• Timeline : The timeline should clearly outline specific tasks for each team/department, including their expected initiation and completion dates, and the project manager will ensure tasks and teams are on track. Clinical trials often get delayed, so it is useful to have protocols in place regarding how to deal with potential delays. [3]
• Budget : Often related to unexpected delays, it is not uncommon for projects to end up over budget. The project plan should clearly define budgets, both for teams and for individual tasks, and should outline how deviations from budgets should be dealt with.
• Stakeholder management : The project management plan should outline the content and dates of formal reports for keeping stakeholders updated about the trial’s progress.
• Documentation : The project plan should outline how documentation should be collected, organized, stored, and verified in order to ensure compliance with laws as well as ethical and clinical standards as established by the WHO and ICH guidelines for Clinical Good Practice.
• Site management : Although site monitoring is usually a separate responsibility in clinical trials, the project plan may include instructions and guidelines for individual study sites regarding adherence to protocol, tasks, and timelines. In addition, sites should have clear guidelines on who to contact in the case of any problems, questions, or adverse events that may arise during the trial.
• Data management : The project plan should specify protocol for the collection, secure storage, management, validation, and cleaning of subject information and trial data, in accordance with quality standards and applicable regulations. Proper data management ties in closely with quality assurance, and sound results require healthy data.

Tips for successful clinical research project planning and management

Here are 4 specific tips and ideas for maximizing the efficacy of project management functions in clinical research.

1. Plan with flexibility

Delays can be hard to avoid, especially in the recruitment stage, and they are costly to sponsors. Nonetheless, proper consideration of these potential delays in the timeline (i.e., allowing for some degree of flexibility) can make the difference between the delays simply setting the trial back a few weeks, or ending in the entire trial being canceled.

While delays aren’t ideal, proper planning can allow the sponsors to absorb these delays without them leading to completely missed deadlines and/or cancellation of the trial; in the end, cancellation likely represents a much more significant waste of resources than delays. The same logic can be applied to flexibility in budgeting, as delays may imply additional costs; if these are less unexpected, they can be better absorbed within the trial budget without setting it entirely off track.

2. Identify possible risks and establish mitigation strategies

Perform a thorough analysis of the protocol and utilize specialist knowledge in the fields of medicine and clinical research management to identify and create a list of risks that could arise throughout the clinical trial. Planning ahead of time will allow sponsors to respond rapidly to these risk factors and mitigate them, without having to perform lengthy analyses and coming up with mitigation strategies when it may be too late.

Some potential risks to consider include recruitment delays or low accrual, adverse events, patient dropouts, protocol breaches, problems with study drug supply or distribution, technical failures (of software systems, medical equipment, etc.), and data integrity issues, to name a few. Start with the risks that pose the greatest threat to the integrity of the study, i.e., those which would result in it being canceled, stopped, or rendering the results unusable.

3. Use project management tools

Constantly reviewing all aspects of the clinical trial is a daunting task, so the use of specialized and customizable software solutions can be helpful. There are many such solutions available, from general project management tools to dedicated clinical trial management systems ( CTMS ). These tools can be of significant help in managing, organizing, and overviewing all of the aspects of project management discussed previously, acting as a sort of central dashboard as well as a “safeguard” for the project management plan and tasks.

4. Leverage data automation tools and functions

Similarly to the previous point, data management is another aspect of clinical trials (and clinical trial project management) that can benefit greatly from the assistance of technological tools. Lots of data management functions, including organization, cleanup, and validation, can be streamlined or even completely automated through data processing tools, which are sometimes integrated directly into CTMS or other clinical trial monitoring solutions. The benefits of healthy data include enhanced regulatory compliance and faster progression to data analysis and results once the study data has been collected. Data can also be improved at the source through the use of electronic reporting/collection/recording methods such as:

• Electronic patient-reported outcomes ( ePRO )
• Electronic trial master files ( eTMF )
• Electronic clinical outcome assessments ( eCOA )
• Electronic case report forms ( eCRF )

Conclusions

Clinical research project management is a vital function for keeping the numerous separate yet highly interconnected parts involved in a clinical trial operating in coordination and on track with protocol, budget, timelines, and regulations. There are numerous strategies and tools that can facilitate clinical trial project management tasks and help improve clinical trial quality and speed while still ensuring patient safety and regulatory compliance.

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Project Management

According to the Business Dictionary (2010),  ‘project management’  is  organisation of work within time, budget and cost limits . A bad project manager, therefore, can be defined as a manager who is unable to arrange project work according to some or all of these constraints. The reasons for this may be a PM’s lack of experience/knowledge or skills and poor communication between concerned parties (which is also due to insufficient training, SOPs, lack of experience or inability to account for previous failures and success).

As highlighted by Rettig, R.A. (2000, p.129), the importance of project management and oversight is crucial in the environment of prevailing commercial approach in pharmaceutical industry. Though it may be safer for Pharma to manage their own R&D projects internally, it becomes more time- and cost-effective to outsource clinical trial and pre-approval activities to specialized CROs. However, it is true that quality of project management services delivered by CROs is often unsatisfactory due to different reasons (Bryde, D.J. and Joby, R., 2007). Among other reasons for such outcome the authors cite the view of British Standards Institute (2003), according to which project management is a service that must be of an appropriate quality, i.e. must satisfy all participating parties. However, projects (even very similar in many aspects) are also unique and, thus, require individual approach based on previous experience.

Indeed,  reasons for failure of a project  and most  significant elements of project success  can be defined as  symmetrical antipodes .  If one would define what a bad project manager could do wrong to cause a project failure, it is possible to   mention instead what a good project manager would do to make a project successful.  The most important elements of a successful project management are  Quality Assurance and project planning  at each step. So, to avoid problems in project management the following must be taken into account by project management team (or a PM):

Houston, S.M. & Bove, L.A. (2007):

• Consistent methodology
• Definition of a project by  limits of time, cost and performance  (OR by scope, cost and time)

EA RHA, 1993 cited in Caan, W., Wright, J. & Hampton-Matthews, S. (1997, p.468):

• Team  with sufficient  knowledge and training
• Support  and  back-up of the organisation

Wycoff, 1991 cited in Caan, W., Wright, J. & Hampton-Matthews, S. (1997, p.469):

• Knowledge that you, as a PM,  can achieve/facilitate achievement of the project            goals
• Planning:  a clear picture for all participants to describe the stage of the project, how  a certain goal was achieved and where/how to move further to reach further goals
• Utilization of project management frameworks, such as PRINCE  (EA RHA, 1993 cited in Caan, W., Wright, J. & Hampton-Matthews, S., 1997, p.469)
• Assessment and re-assessment of  risks = development and subsequent adjustment of the initial project plan

Besides, a good project manager would ask him/her-self the following questions and make the answers clear to other team members  (Caan, W., Wright, J. & Hampton-Matthews, S., 1997):

–          Why certain steps are maid =  what result is expected

–           What is required  for goals achievement

–          Who should do what and when:  Development of the Communication Plan

–          Whether everything needed is in place to start

–          When and whether the project is completed

–           What lessons have been learnt from this project

–           What can be done to improve further performance

So, to make a project successful a PM must: be experienced, have appropriate team and support, plan accordingly, communicate, make corrections, learn from previous mistakes/success, implement gained knowledge.

References:

Bryde, D.J. and Joby, R. (2007) ‘Importance of project and project management deliverables in clinical trials’ , R&D Management , 37(4), pp. 363-377.

Business Dictionary (2010)  Project Management  [Online]. Available from:  http://www.businessdictionary.com/definition/project-management.html .

Caan, W., Wright, J. & Hampton-Matthews, S. (1997) ‘Start as you mean to go on:  Project management for beginners’,  Journal of Mental Health , October, 6(5), pp. 467-472.

Houston, S.M. & Bove, L.A. (2007)  Project Management for Healthcare Informatics , Springer (New York), Chapter 1 ‘Project Management Process’, pp. 1-14 .

Rettig, R.A. (2000) ‘The Industrialisation of Clinical Research’,  Health Affairs , Vol 19, Issue 2, pp. 129-146.

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What to know about project management for clinical trials.

Completing any multi-part task requires organization, coordination, and discipline — and, of course, clinical trials are no exeption. Planning a research study, launching a trial, and keeping things running smoothly requires knowledge and expertise, which is why clinical trial project managers are so vital to the process.

From creating a plan, communicating updates, calculating risks, and addressing any mistakes that arise , solid project management is a necessity to ensure medical research is allowed to move forward. Here, we’ll discuss the role of the clinical trial project manager, as well as tips for developing project plans, stakeholder involvement, communication, IRB submission, and summarizing lessons learned.

What is project management in clinical trials?

The Project Management Institute (PMI) defines project management as the "application of knowledge, skills, tools, and techniques to project activities to meet the project requirements." Project management combines expertise in scope, time, cost, quality, risk management, communication, and stakeholder management in order to move through the five basic phases of any project :

• Project initiation. This phase involves developing an idea, understanding the necessity of the project, and identifying the key decision-makers
• Project planning. This is the phase for making a plan and outlining the work required, including prioritization, budget, schedule, and resources
• Project execution. This is where tasks are distributed by informing all teams of their responsibilities and deadlines
• Project monitoring. This entails implementing project tracking to compare the current project status and progress with the original plan, adjusting as needed
• Project closure. The final phase, where project managers reflect on project success and key learnings for next time

When concerning clinical trials, project management brings all of these phases together to ensure set up, enrollment, operations, and reporting are all done smoothly and effectively. 

Roles of a clinical trial project manager

A clinical trial project manager may have different responsibilities specific to each trial, but in general, they will be tasked with vendor selection, budget oversight, IRB submissions, report creation, and meeting planning, all of which are detailed below.

Vendor selection: Because conducting a clinical trial requires many different elements, outside vendors will often be brought in to provide expertise in certain aspects of a study. This is most common for specialized elements such as Interactive Web Response Systems (IWRS) , electronic patient-reported outcome (ePRO) technology, and clinical trial patient recruitment . Often, it will be the project manager's job to vet these vendors and assist with comparing options.

Timeline and budget oversight: Though every study begins with a specific timeline and budget, nearly 80% of all clinical trials are delayed due to difficulties in patient recruitment, which causes many to exceed their budget. In these situations, a project manager can leverage their expertise to hold the trial team accountable for the time and money spent on the study, in addition to managing expectations should these elements begin to change. 

IRB submissions: Any patient-facing materials involved in research studies must be reviewed and submitted for Institutional Review Board (IRB) approval, and gathering these materials is often the responsibility of the clinical trial project manager. Because every IRB is different, the project manager will need to look at previous submissions and any templates that are available to ensure the study's particular IRB requirements are met.

Report generation: As part of tracking the progress of a trial, clinical trial project managers should regularly generate and distribute reports on various aspects of a study’s progress. These reports can often be automated so they are not a time-consuming task, but they do play an essential role in keeping key stakeholders looped in on the progress of the research.

Meeting coordination: Occasionally, the trial’s key stakeholders may need to meet to review a trial’s progress and address any roadblocks. The project manager will likely be charged with planning and leading these meetings to ensure that all details are covered and relevant updates are provided.

Tips for effective project management in clinical trials

Create a detailed project plan

One of the best ways to circumvent delays and issues in a clinical trial is to create a detailed project plan before the study launches. This plan should include a timeline of milestones, key dates, a task schedule, and any other relevant pieces that can keep the project on track. Some people may prefer pen and paper for this, but there are also many online resources available to help project managers keep track of details and stay on schedule.

Anticipate risk management demands

Every project will have some level of risk, so it’s wise to acknowledge what points of contention may arise and plan accordingly. A few examples of risks associated with clinical trials include:

• Long wait times for IRB approval
• Delays in patient recruitment
• Turnover among site staff
• Changes to the trial protocol

Before the project starts, it can be helpful to come together as a team to discuss potential risks that may arise, share past experiences, and determine how they can be prevented or handled if they do arise.

Understand IRB requirements

In most studies, the project manager will also be tasked with gathering materials and submitting them for approval from the Institutional Review Board (IRB). Every IRB will vary on its guidelines, but IRB administrators should be able to answer any questions to ensure a smooth and efficient process.

Even if the responsibility of IRB submission is a task for the project manager, it can be helpful to enlist additional team members to provide a second set of eyes before the materials are submitted. It is also wise to create a checklist of elements that should be included in the IRB packet to ensure nothing gets left out.

Foster open communication between sites and sponsors

Another important communication piece for project managers is to share feedback from sites back with the sponsor of the trial. Communication is particularly important in relation to sharing updates with sponsors about recruitment or screening challenges the site may be facing. 

Communication tips for project management

One of the most important jobs of a clinical trial project manager is to ensure clear and effective communication with multiple stakeholders. To manage this communication from the onset, it can be useful to create a list of stakeholders, the updates they'll need, and how often they should be informed.

To manage this communication, the RACI project management method can provide a helpful framework to organize stakeholders into four categories based on their involvement in the project and communication needs.

• Responsible: The responsible party is the main point person for communication – this is the stakeholder who does the actual work of this part of the project. For example, when submitting outreach material to the IRB, the person responsible for creating the material may be the lead on the marketing team or the contact at a clinical trial recruitment company.
• Accountable: The accountable person is generally the manager of the responsible party and may wish to be involved in only some of the updates related to the project. Generally, if the responsible party needs approval from their manager, they should do so before sharing updates more broadly.
• Consulted: The consulted party would be any additional stakeholders who should weigh in on a project. The responsible or accountable party can generally help project managers determine who should be involved in the consultation.
• Informed: These are people who are simply kept up-to-date on the progress of the project at appropriate intervals.

A paper on managing clinical trials published by the National Institutes of Health also mentions the importance of keeping the investigators themselves in the loop about a trial, stating, "Investigators need to feel valued and part of an inclusive team answering an important clinical question, so providing regular feedback that ensures they feel involved must be central to a trial's communication strategy." Because the investigators may also have busy clinical practices in addition to being part of the trial, it’s important to respect their time while making them feel involved and informed.

Project managers’ roles after a clinical trial

Project management is an ever-evolving skill and there are lessons to be learned from even the most successful project execution. It’s important that project managers evaluate each trial after it's complete in order to analyze trends and plan for the next one while key learnings are still top of mind. As Hubspot puts it, "a productive project post-mortem is a chance to fully unpack a project's trajectory and dig deeper into why things unfolded the way they did.”

Hosting a project post-mortem meeting involving key stakeholders is advisable. Sending a pre-meeting questionnaire can streamline the process of gathering thoughts on what went well, what didn't, and what could be done better next time. The agenda should include a recap of the project's goals and a review of the results so that any discrepancies can be addressed and everyone is able to come up with actionable takeaways for the future.

If you're interested in learning more about how Antidote begins the clinical trial recruitment process and manages the project throughout, download our recruitment template below.

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SOPs and Associated Documents-Templates

The Research Governance and Integrity Team (RGIT) has produced Standard Operating Procedures (SOPs) and associated templates for Imperial College investigators and research staff, governing the management and operational aspects of conducting clinical research.

This section contains the RGIT approved:

• Standard Operating Procedures (SOPs)
• Associated document: covers guidance and templates associated with the RGIT SOPs
• Non- associated documents (which may cover guidance notes or templates etc)

Please note, all SOPs are referenced with RGIT_SOP_XXX and the associated templates are referenced with RGIT_TEMP_XXX. The SOPs are all in PDF format and the SOPs are generic, please adapt them to make study-specific procedures. The associated documents and templates will be made available in Word format for ease of completion.

Please refer to this page often as the most up-to-date version of each SOP will appear on this page. I f you have any questions please contact a member of the RGIT .

Please note the new IRAS system for CTIMP studies will be mandated by the HRA from 1st January 2022, the RGIT will therefore not be accepting old IRAS application forms for sponsorship review from the 1st October 2021. Information on the new system can be found here .

SOP, Associated Documents/Templates

RGIT_SOP_012_Protocol_design_v12.pdf ‌‌ ‌

• RGIT_TEMP_026_Template Protocol for CTIMPs_v5.docx ‌ ‌
• ‌ RGIT_TEMP_027_Template-Protocol-for-non-CTIMPs_V7.docx ‌

Ethics and consent

RGIT_SOP_002_Ethics_Approval_for_Health_Related_Research_v10.pdf

• RGIT_TEMP_007_Research Governance and Integrity Team Contact Details_v2.docx
• RGIT_TEMP_008_Summary-of-Where-to-Apply-for-Ethics-Approval_v2.docx

RGIT_SOP_006_Amendments_V12.pdf

• RGlT_TEMP_015_v1.6.xlsm

RGIT_SOP_003_Applying for NHS REC Approval.pdf

• RGIT_TEMP_010_IRAS Content Index - Integrated Dataset.docx

RGIT_SOP_016_Informed_Consent_v.20.pdf

• RGIT_TEMP_031_Guide-to-Writing-a-Participant-Information-Sheet_v.7.docx
• RGIT_TEMP_032-Template-ICF-for-Adults-with-Capacity_V6.docx
• RGIT_TEMP_033_Template-ICF-for-Adults-without-Capacity_V7.docx
• RGIT_TEMP_034-Template-ICF-for-Parent-legal-guardian-minor rep._V6.docx

Imperial College Healthcare Trust

RGIT_SOP_031_Imperial College Healthcare Trust approval.pdf

• RGIT_TEMP_009_Divisional-Research-Managers-and-Feasibility-Facilitators.docx ‌
• RGIT_TEMP_043_Email Templates for ICHT Confirmation of CCC.docx

RGIT_SOP_032_Imperial College Healthcare Trust amendment approval.pdf

RGIT_SOP_038_ICHT Trust Approval No REC.pdf ‌

NIHR studies

RGIT_SOP_033_NIHR_V9.pdf

• RGIT_TEMP_044_EligibilityCriteria for NIHRClinicalResearchNetworkSupport_V3.docx
• RGIT_TEMP_045_NIHR Non-commercial Partner List_V3.docx

Safety reporting

RGIT_SOP_001_Safety_Reporting_v13.pdf

• RGIT_TEMP_003_Example Serious Adverse Event form_V4.docx
• RGIT_TEMP_004_Safety Reporting Overview_v2.docx
• RGIT_TEMP_006_CTIMPs Safety Report Form_v3.docx

RGIT_SOP_021_Serious Breach Reporting_v9.pdf

RGIT_SOP_035_Development Safety Update Report.pdf ‌

• RGIT_TEMP_047_Development Safety Update Report Template.docx

RGIT_SOP_037_Deviations_Violations_USM_v7.pdf ‌

RGIT_SOP_041_ Annual_Progress_Report_v5.pdf

Essential documentation and TMF

RGIT_SOP_005_TMF_Guidance_v.10.pdf

• RGIT_TEMP_012_Essential Documents to be maintained with a TMF_V3.docx
• RGIT_TEMP_013_Example Checklist for Inclusion with ResearchProject Files_V3.docx
• RGIT_TEMP_014_RGIT & Site Contact Details_V3.docx ‌

Case Report Form

‌ RGIT_SOP_007_CRF_design_v12.pdf

• RGIT_TEMP_016_Example CRF sign-off sheet_V4.docx ‌
• RGIT_TEMP_017_Example randomisation form_V4.docx ‌

Sponsorship and indemnity

RGIT_SOP_009_AHSC_approval_V14.pdf

• RGIT_TEMP_019_CI-agreement-for-CTIMPs_V2.docx ‌
• RGIT_TEMP_020_Risk-Assessment-Tool_V2.docx ‌
• RGIT_TEMP_021_Sponsorship-and-Insurance-Request-Form_V17.docx
• RGIT_TEMP_022_OID-Contracts-Flowchart-_v.6.docx
• RGIT_TEMP_054_CTIMP-Addendum-Risk-Assessment_ V9.docx ‌‌ ‌
• RGIT_TEMP_057_Sponsorship-and-Insurance-Approval-email_V11.docx ‌ ‌
• RGIT_TEMP_058_Statistical-Engagement-Letter_V1.docx ‌
• RGIT_TEMP_062_Process Map for OID and SoECATs.pdf ‌ ‌

Approval bodies

RGIT_SOP_004_GTAC_application_v10.pdf

• RGIT_TEMP_011_GTAC Decision Tree_v3.docx

RGIT_SOP_008_CTA_MHRA_v14.pdf

• RGIT_TEMP_015_v1.6.xlsm
• ‌ RGIT_TEMP_073_RGIT-CTIMP-Decision_v2.docx

RGIT_SOP_014_Medical Device.pdf

• RGIT_TEMP_028_Guidance Notes for Medical Devices.docx

RGIT_SOP_017_CAG_application_V12.pdf

RGIT_SOP_023_HFEA License Applications_v9.pdf ‌

RGIT_SOP_039_HRA_Approval_v6.pdf

RGIT_SOP_050_Medical Device Safety Reporting.pdf ‌

• RGIT_TEMP_005_SAE Reporting Form for non-IMP studies.docx
• RGIT_TEMP_063_Medical Device SAE Reporting Form.docx ‌
• RGIT_TEMP_064_Medical Device Report Form.docx ‌

Monitoring and audit

RGIT_SOP_015_Monitoring_v10.pdf ‌

• RGIT_TEMP_029_Monitoring Risk Assessment_v3.docx
• RGIT_TEMP_030_Monitors responsibilities under ICH GCP_v3.docx ‌

RGIT_SOP_018_Audit_v.11.pdf ‌

• ‌ RGIT_TEMP_071_Remote-Access,-Monitor-&-Auditor-Declaration-Form_v2.docx ‌

RGIT_SOP_049_ICHT_Remote_Monitoring_v4.pdf ‌

• RGIT_TEMP_071_Remote-Access,-Monitor-&-Auditor-Declaration-Form_v2.docx ‌

Trial management

RGIT_SOP_013_Participant_Complaints_v9.pdf

RGIT_SOP_019_Archiving_v10.pdf

• RGIT_TEMP_035_Transferring Records to Archives Corporate Records Unit_V2.docx

RGIT_SOP_020_Data_Management_v11.pdf

RGIT_SOP_022_Public Databases.pdf ‌

RGIT_SOP_024_Training_v9.pdf

• RGIT_TEMP_036_Template Curriculum Vitae (CV)_V3.docx

RGIT_SOP_025_QA&QC_v9.pdf

RGIT_SOP_026_IMP Management.v10.pdf

• RGIT_TEMP_037_Study Delegation Log_v.3.docx
• RGIT_TEMP_038_Subject Dispensing and Return Accountability Log.v3.docx
• RGIT_TEMP_039_Drug Accountability Log.v3.docx
• RGIT_TEMP_040_Investigational Medicinal Product Destruction Log.v.3.docx
• RGIT_TEMP_051_Annex 13 labelling requirements for CTIMPs.v2.docx

RGIT_SOP_027_Equipment_Maintenance_v9.pdf

RGIT_SOP_029_Laboratory_Procedures_v9.pdf

RGIT_SOP_030_Computerised Systems.pdf

Research passports

RGIT_SOP_034_Honorary_Research_Passport_v7.pdf

Research misconduct

RGIT_SOP_036_Fraud and Misconduct.pdf

RGIT_SOP_011_SOP_Writing Reviewing_v10.pdf

• RGIT_TEMP_001_SOP Read and Acknowledge Signature Log_V3.docx ‌
• RGIT_TEMP_023_SOP Template_V3.docx
• RGIT_TEMP_024_Statement of Compliance to RGIT SOPs v3.docx
• RGIT_TEMP_025_RGIT Log of approved waivers v3.xlsx

RGIT_SOP_040_Peer_Review_v4.pdf

• RGIT_TEMP_048_Peer Review levels grid_v.8.docx
• RGIT_TEMP_049_Reviewer Suggestion Form_V3.docx

RGIT_SOP_028_End_of_Study_Procedure_V14.pdf

• RGIT_TEMP_041_Notification End of Clinical Trial Medicine_V3.docx
• RGIT_TEMP_042_Declaration of the End of a study_V5.docx

RGIT_SOP_042_Incidental Findings_v3.pdf

RGIT_SOP_043_Electronic Signature.pdf

RGIT_SOP_046 Database Lock.pdf

RGIT_SOP_048_Vendor Assessment_V3.pdf

• RGIT_TEMP_055_Vendor Pre-Questionnaire_V7.docx
• RGIT_TEMP_061_Laboratory GCP Questionnaire for CTIMPs_V2.docx

ICREC-SETREC

RGIT_SOP_044_ICREC SETREC_Ethics_Application_Process_V6.pdf

• RGIT_TEMP_075_ICREC Participant Information Sheet_V3.docx
• RGIT_TEMP_076_SETREC Participant Information Sheet_V3.docx
• RGIT_TEMP_077_ ICREC Consent Form_V2.docx
• RGIT_TEMP_078_ SETREC Consent Form_V2.docx
• RGIT_TEMP_080_ICREC_SETREC_Undergraduate-Proposal-Checklist_v4.docx

RGIT_SOP_045_ICREC_Safety_Reporting_V5.pdf

Non-Associated Documents

‌ RGIT_TEMP_059_Reference Safety Information Guidance for Clinical Trials.docx ‌

RGIT_TEMP_060_RGIT CTIMP COVID Study Self Risk Assessment.docx

RGIT_TEMP_065_RGIT Filenote.docx ‌

RGIT_TEMP_066_Protocol-Violation-and-Deviation-Form_V4.0_21Dec2022 ‌

RGIT_TEMP_074_Study Start Approval Form (SAAF).docx

• UNC Chapel Hill

SOPs for Clinical Research

Ighid clinical research sop template overview.

The SOP templates offered on this site are geared towards outpatient clinical research. They can be used by any research site around the world but their focus is on sites who are part of the Institute for Global Health and Infectious Diseases at UNC. Developing SOPs and procedures is a time-consuming process that requires years of experience and dedicated administrative time. These templates are a resource designed to expedite the process of site readiness. They are easily adapted with highlighted areas geared to stimulate discussion at the site on how make a process work for your local context.

The SOP categories are divided into Administrative, Principal Investigator (PI) oversight, Clinical Management and Participant Safety, and Data Management. The Tools for Research folder provides quick access to well-developed and commonly used tools in research.

IGHID Regulatory has a set of SOPs focused on IRB submissions and maintenance of essential documents. Please email the IGHID Regulatory Director, Tania Hossain at [email protected] to request access. Pharmacy and laboratory SOPs are not included. For laboratory processes, please contact the UNC Global CTU Laboratory Manager, Amy James at [email protected]

SOP Development

The SOPs are adapted from experienced IGHID research projects and encopmas studies that undergo regular site monitoring from DAIDS and Industry sponsors along with sponsor audits. The SOPs and workflows described have been refined over the years and have produced clear staff roles, a focus on continuous quality improvement, participant safety, and high-quality data.

How to use the Templates

Each SOP template is housed in Microsoft Office Word OneDrive document. The original documents are locked for editing but once copied, you can edit as needed. Each document has comments or red writing to indicate what information is most likely need to be adapted to your site. Please note that this is a complete set of SOPs that cross-refers to other SOPs in the set. The References section lists each SOP that is cross-referenced. If you are using a single SOP as an addition to your own set, update the Reference section to direct the reader to the correct SOP. Headers and footers in the document can only be viewed when the document is opened in the desktop Microsoft Word application.

UNC ONYEN Affiliates

All UNC affiliates with an ONYEN should be able to open the word documents below that are housed on an internal UNC SharePoint site. If you would like to copy the entire SharePoint (SP) site, please request access below. You can copy the OneDrive folder or SharePoint site, then modify all the documents on your own site. The advantage of having the SP site is that all the SOPs can be easily organized at a glance with who is document owner, dates for renewal or archive, and more. The SOP list and all the columns associated with the SOPs can be exported into an excel document.

UNC Non-Onyen Affiliates

If you are a UNC affiliate without an ONYEN, please request access below to the SharePoint site. Please note which UNC research site you are affiliated with and the site PI.

Administrative (AD)

• IGHID Clinical Research Acronyms and Definitions Template
• SOP – AD-00 – IGHID Clinical Research SOP Template
• SOP – AD-01 – SOP Creation, Review and Training Template
• SOP – AD-02 – Deferring to IGHID and Outside Group’s SOPs Template
• SOP – AD-03 – Protocol Training Template
• SOP – AD-04 – Site Staff Responsibility and Communication of Protocol Implementation Template
• SOP – AD-05 – Language Requirements for Research Staff Template
• SOP – AD-06 – Monitoring Visits Staff Responsibilities Template

Clinical Management and Participant Safety (CS)

• SOP – CS-01 – Study Start-up Meeting Template
• SOP – CS-02 – Serious Adverse Event (SAE) and Expedited Adverse Event (EAE) Template
• SOP – CS-03 – Adverse Event (AE) Management Template
• SOP – CS-04 – Recruitment, Screening, Enrollment and Retention of Study Participants Template
• SOP – CS-05- Blood Volume Monitoring Template
• SOP – CS-06 – Scope of Practice for Non-Licensed Clinical Staff Template
• SOP – CS-07 –  Infectious Disease Counseling, Testing and Referral Template
• SOP – CS-08 – Co-Enrollment Prevention Template
• SOP – CS-09 – Unblinding Study Participants Template
• SOP – CS-10 – Investigational Product Transport and Temporary Storage Template
• SOP – CS-11 – Pharmacy Responsibilities Template
• SOP – CS-12 – Physical Exam Template
• SOP – CS-13 – Obstetric Referral Plan Template
• SOP – CS-14 – Medical Management at the Research Location Template
• SOP – CS-15 – Infection Control at the Research Location Template
• SOP – CS-16 – Suicidal and Homicidal Study Participant Management Template

Data Management (DM)

• SOP – DM-01 – Source Documentation and Data Collection Guidelines Template
• SOP – DM-02 – Research Quality Management, CRF Completion and CAPAs Template
• SOP – DM-03 – Data Access, Security and Facilities Template
• SOP – DM-04 – Screening and Enrollment Logs Template
• SOP – DM-05 – Paper Source Documentation Development and Research Record Organization Template

Principal Investigator Oversight (PI)

• SOP – PI-01 – Supervision of Clinical Trials Staff Template
• SOP – PI-02 – Delegation of Duties (DoD) log Template

Tools for Research

• Data Management Tools
• Regulatory Tools
• Source Document Tools
• Visit Checklist Templates
• Visit Logs Templates

Your Feedback is essential!

Research requires continuous quality improvement in all areas.

Please let us know if you would like access to the SharePoint site to copy (available to UNC Affililiates only), have a suggestion, or need an SOP for your site.

SOP Clinical Research Feedback

Contact information, do you have an sop to share with ighid.

Please email Becky Straub, [email protected] if you have an SOP that other IGHID researchers could benefit from.

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The Importance of Standard Operating Procedures (SOPs) in Clinical Research: Enhancing Quality and Compliance

Standard Operating Procedures (SOPs) are a cornerstone of effective clinical research, providing clear guidelines and instructions for consistent practices.  SOPs are detailed, written procedures that outline standard practices and processes within an organization or research setting. They serve as a roadmap, ensuring that everyone involved follows the same steps and protocols.

Dr. Peace Chikezie

Published 20 Jul 2023

Standard Operating Procedures (SOPs) are a cornerstone of effective clinical research, providing clear guidelines and instructions for consistent practices. 

In this blog post, we will describe the importance of SOPs in clinical research, their relationship with Quality Management Systems (QMS), and highlight best practices for their development and implementation for a successful clinical trial.

What are SOPs in Clinical Research?

SOPs are detailed, written procedures that outline standard practices and processes within an organization or research setting. 

They serve as a roadmap, ensuring that everyone involved follows the same steps and protocols.

Example: In a clinical trial , an SOP for subject screening and recruitment would outline the criteria for selecting participants, the process for obtaining informed consent, and the steps for verifying eligibility.

What are the Key Elements of a Well-Written SOP? 

A well-crafted SOP should possess key elements that contribute to its clarity and effectiveness:

1. Objectives and Definitions: Clearly state the purpose of the SOP and include definitions of key terms to eliminate ambiguity.

Example: In an SOP for data management, the objective could be to outline procedures for data collection, storage, and analysis, while defining terms such as "data entry" and "data validation."

2. Responsibilities and Procedures: Clearly define who is responsible for each step and provide detailed instructions for carrying out the procedure.

For instance, an SOP for adverse events reporting would specify the roles of the principal investigator , research coordinator, and sponsor, along with the specific steps for documenting and reporting adverse events.

3. References to Regulations and Guidelines: Include relevant regulatory requirements and guidelines to ensure compliance and adherence to industry standards.

Referencing ICH E6 Good Clinical Practice guidelines  and applicable local regulations in an SOP for regulatory document submission ensures alignment with regulatory expectations.

4. Maintaining Consistency and Compliance

SOPs play a crucial role in maintaining consistency and adherence to regulations throughout the research process.

In a multi-site clinical trial, SOPs ensure that all participating sites follow the same procedures, minimizing variations in data collection and ensuring reliable results. 

Moreover, adherence to SOPs ensures compliance with ethical standards, patient safety guidelines, and regulatory requirements .

Quality Management Systems (QMS) in Clinical Trials

A Quality Management System (QMS) is a complete system that includes processes, procedures, and policies to guarantee research quality and compliance with regulations.

In clinical trials, a QMS is like a roadmap that guides researchers and organizations to ensure top-notch quality and compliance with regulations. For example, the QMS helps them set clear quality goals, implement strategies to handle potential risks, and regularly check and evaluate their progress to maintain high standards throughout the research process.

What are the Key Components of a QMS?

A robust QMS comprises several essential components:

1. Documentation and SOPs: SOPs form a crucial part of the documentation within a QMS, providing standardized procedures for various research activities.

2. Training and Competency: Adequate training ensures that research staff understands and follows SOPs, promoting competence in carrying out research tasks.

3. Risk Management: QMS involves identifying, assessing, and reducing risks during the research project to protect participants and ensure successful trials.

4. Auditing and Monitoring: Regular audits and monitoring activities ensure that SOPs and quality standards are being followed and maintained throughout the research project. For Example, Internal audits and monitoring visits by sponsors or regulatory authorities help identify deviations from SOPs, ensuring compliance and maintaining quality.

Benefits of Implementing SOPs in Clinical Research

A. Ensuring Regulatory Compliance and Adherence to Guidelines

SOPs help organizations meet regulatory requirements, ensuring compliance with local regulations, and international guidelines such as Good Clinical Practice (GCP), and ethical standards.

B. Enhancing Data Integrity and Accuracy

SOPs establish standardized procedures for data collection, management, and reporting, ensuring data integrity and accuracy.

C. Facilitating Knowledge Transfer and Onboarding of New Staff

SOPs enable smooth knowledge transfer and onboarding of new staff members, ensuring consistent practices and maintaining continuity within the research team.

New research coordinators can refer to SOPs for subject screening and recruitment to understand the procedures and ensure uniformity in participant selection.

D. Reducing Risks and Ensuring Patient Safety

SOPs include safety protocols, helping identify and minimize potential risks to trial participants, and ensuring their safety throughout the research process.

E. Supporting Efficient and Effective Trial Execution

SOPs streamline processes and promote efficiency, reducing time and resource wastage, thereby contributing to the successful and timely completion of clinical trials.  For instance, SOPs for monitoring visits allow for efficient assessment of trial progress and identification of any deviations.

In the complex and regulated world of clinical research, SOPs and a robust QMS are vital for maintaining quality, consistency, and compliance. 

Infiuss Health stands out as a prominent patient recruitment platform in Africa, dedicated to facilitating seamless clinical trials across the continent.

As clinical research continues to evolve, organizations must prioritize the development, implementation, and maintenance of SOPs. 

Q: What is the difference between protocol and SOP in clinical trials?

A: In clinical trials, a protocol is a detailed plan outlining the objectives, design, methodology, and procedures of the study.  It serves as a blueprint for conducting the research. 

On the other hand, a Standard Operating Procedure (SOP) is a step-by-step guide that defines routine activities and processes within a clinical trial. 

While the protocol provides the overall study plan, SOPs offer specific instructions for carrying out various tasks in a standardized manner.

Q: Who is responsible for writing SOPs in clinical trials?

A: SOPs are typically developed and written by experienced researchers, subject matter experts, or designated quality assurance personnel . These individuals possess the necessary expertise to ensure that the SOPs align with regulatory requirements, industry best practices, and the unique needs of the clinical trial.

Q: Does GCP require SOPs?

A: While GCP does not enforce SOPs as an absolute requirement, they are considered a best practice within the clinical research community. 

Many regulatory authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), expect clinical trials to have SOPs in place to ensure that research is conducted in a standardized and reliable manner.

Q: What are the most common types of SOPs?

A: The most common types of SOPs in clinical trials include:

a. Informed Consent Process and Documentation

b. Data Management

c. Adverse Events and Serious Adverse Events Reporting

d. Subject Screening and Recruitment

e. Protocol Deviations

f. Regulatory Document Submission Process

g. Drug/Device Storage, Accountability, and Management

h. Monitoring Visits

i. GCP Training

Q: What are the 3 components of SOPs?

A: SOPs typically consist of three key components:

a. Objectives : Clearly state the purpose and scope of the SOP.

b. Procedures : Provide step-by-step instructions for carrying out specific tasks or processes.

c. Responsibilities : Identify the roles and responsibilities of individuals involved in the process.

Q: What are the steps in creating an SOP?

A: The steps in creating an SOP include:

a. Identify the process or activity to be documented.

b. Gather input from relevant stakeholders and subject matter experts.

c. Draft the SOP, ensuring it aligns with regulatory guidelines and best practices.

d. Review and revise the draft based on feedback and input.

e. Obtain approval from appropriate authorities before implementation.

f. Ensure proper training and communication of the SOP to all relevant personnel.

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Clinical Research Standard Operating Procedures

List of Standard Operating Procedures

• SOP #101- Writing SOPs
• SOP #102 - Training Personnel
• SOP #103 - Responsibilities of Research Team
• SOP #104 - Conduct of Clinical Study
• SOP #105 - Document Control
• SOP #201 - Regulatory Documentation  (regulatory binder)
• SOP #202 - Privacy and Confidentiality
• SOP #203 - IRB Submission
• SOP #204 - Adverse Event Reporting
• SOP #205 - Conflicts of Interest
• SOP #301 - Study Feasibility
• SOP #302 - Site Qualification visit
• SOP #303 - Site Initiation visit
• SOP #304 - Communication Practices
• SOP #305 - Investigational Product Accountability
• SOP #306 - Randomization and Blinding
• SOP #307 - Venipuncture
• SOP #308 - Specimens Collection and Management
• SOP #309 - Preparing Injectable Medications
• SOP #310 - Site Monitoring Visit
• SOP #311 - Site Closeout Visit
• SOP #312 - Protocol Compliance
• SOP # 401 - Subject Recruitment
• SOP #402 - Informed Consent
• SOP #403 - Eligibility and Enrollment
• SOP #404 - Protecting Confidentiality of Study Subjects
• SOP #405 - Study Visits
• SOP #406 - Payments to Subjects
• SOP #501 - Case Report Forms
• SOP #502 - Source Documentation
• SOP #503 - Electronic Records
• SOP #504 - Archiving Study Records
• SOP #505 - Printing and Certifying Medical Records
• SOP #601 - Quality Control 
• SOP #602 - FDA Audits
• SOP #603 - Corrective and Preventative Action Plan
• SOP #604 - Equipment Maintenance and Calibration
• SOP #605 - Temperature Monitoring
• Source Documentation Checklist
• Research Involving Animals (IACUC)
• Research with Human Subjects (IRB)

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Project Manager Associate-MaineHealth Institute for Research

Mainehealth | scarborough, me, united states.

Position Summary

This position is for someone interested in joining a research coordination team within the Center for Clinical & Translational Science at the MaineHealth Institute for Research , Scarborough, ME. The Project Manager Associate will contribute to biomedical science by supporting research investigators and study team members and facilitating the coordination and management of research activities, specifically the Long COVID research program, in a manner that promotes participant safety and best practices in clinical research, in accordance with federal regulations and local institutional processes.

This position provides clinical project management support for four Long COVID studies: RECOVER (observational study to understand all the Long COVID symptoms), PROMIS (observational study to determine why some people get Long COVID), ENERGIZE (an interventional study for participants with the Long COVID symptom of exercise intolerance), and IMMULINA (an interventional study for participants with the Long COVID symptom of high inflammation). Under the supervision of the Research Program Director, Dr. Ivette Emery , the Project Manager Associate will assist the study team with the management of all study documents, including all regulatory documents, and with the management of study meetings (including preparing agendas and taking minutes) as well as participant study visits. In addition, the Project Manager Associate will be involved in the planning, implementation, and post implementation phases of various strategic projects with the goal of improving clinical, administrative, financial systems, and/or the infrastructural systems for the benefit of our patients and staff. This position will independently manage projects of limited complexity. This work requires initiative, independent judgment and discretion.

This position is for on-site work located at one of our Scarborough, Maine locations.

The MaineHealth application, a cover letter and a resume or CV are all required elements for application.

Required Minimum Knowledge, Skills, and Abilities (KSAs)

Education: Bachelor’s Degree or equivalent work experience in Information Technology, Project Management and/or completion of project management coursework required.

License/Certifications: N/A

Experience: Previous healthcare experience preferred.

Additional Skills/Requirements Required: N/A

Additional Skills/Requirements Preferred: Strong communication and presentation skills and ability to present to project team audiences. Strong analytical and problem solving skills.

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Kemerovo Oblast—Kuzbass

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Kemerovo Oblast—Kuzbass is situated in southern central Russia. Krasnoyarsk Krai and Khakasiya lie to the east, Tomsk Oblast to the north, Novosibirsk Oblast to the west, and Altai Krai and the Republic of Altai to the south-west. Kemerovo was founded in 1918 as Shcheglovsk. It became the administrative centre of the Oblast upon its formation on 26 January 1943. The city is at the centre of Russia’s principal coal mining area. In 1998 Tuleyev signed a framework agreement with the federal Government on the delimitation of powers, which was accompanied by 10 accords aimed at strengthening the regional economy. The Oblast’s main industrial centres are at Kemerovo, Novokuznetsk, Prokopyevsk, Kiselyovsk and Leninsk-Kuznetskii. Kemerovo Oblast’s agriculture consists mainly of potato and grain production, animal husbandry and beekeeping. The Oblast is the largest producer of coal among the federal subjects, and a principal producer of steel.

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Transformation of the Development Model for Kemerovo Oblast as a Resource Territory

• INSTITUTIONAL PROBLEMS OF REGIONAL DEVELOPMENT
• Published: 16 December 2020
• Volume 10 , pages 467–475, ( 2020 )

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• Yu. A. Friedman 1 ,
• G. N. Rechko 1 &
• E. Yu. Loginova 1  

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In Kemerovo oblast—the Kuzbass—together with the change in regional power, the Strategy for the Socioeconomic Development until 2035 (Kuzbass-2035) was developed and adopted. The main drivers of the region’s development are the reindustrialization policy, accelerated rates of socioeconomic growth, and widespread clustering. The idea of a “two-year leap” (2018–2019) was also announced. The Kuzbass, according to the authors of the strategy, should be the leading region outside the Urals in terms of development rates and standard of living. At the same time, this rationale is neither based on the economic realities prevailing in the region or the assessment of its competitiveness. The authors of the article put forward a hypothesis that all Kuzbass development strategies over the past two decades have failed due to the discrepancy between the resource character of the region and its applied development models. The aim of the article is to select models for the development of Kemerovo oblast and to formulate proposals for their transformation and synchronization with the developed regional development strategy. The results of the study can be used for managing Kemerovo oblast, especially in the development and implementation of mechanisms for harmonizing the interests of business, society, and government.

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Institute of Economics and Industrial Engineering, Siberian Branch, Russian Academy of Sciences, 630090, Novosibirsk, Russia

Yu. A. Friedman, G. N. Rechko & E. Yu. Loginova

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Correspondence to Yu. A. Friedman , G. N. Rechko or E. Yu. Loginova .

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Friedman, Y.A., Rechko, G.N. & Loginova, E.Y. Transformation of the Development Model for Kemerovo Oblast as a Resource Territory. Reg. Res. Russ. 10 , 467–475 (2020). https://doi.org/10.1134/S2079970520040048

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Received : 02 July 2019

Revised : 10 July 2020

Accepted : 20 July 2020

Published : 16 December 2020

Issue Date : October 2020

DOI : https://doi.org/10.1134/S2079970520040048

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