Project Management in Clinical Trails

Project management is a critical aspect of clinical trials, which involves coordinating and managing various activities and resources to ensure that the trial is completed on time, within budget, and with high quality data. Here are some key components of project management in clinical trials:

Planning: This involves developing a comprehensive project plan that outlines the timeline, budget, resources, and activities required for the trial.

Team building: Building an effective project team with the necessary skills and expertise is essential for the successful completion of a clinical trial.

Risk management: Identifying and managing risks associated with the trial is crucial to minimize their impact on the study.

Protocol development: The development of a detailed study protocol, including study design, patient selection criteria, and data collection and analysis, is essential for the success of the trial.

Regulatory compliance: Ensuring compliance with all regulatory requirements and ethical standards is critical for the protection of study participants and the integrity of the study data.

Monitoring: Monitoring the progress of the trial, including recruitment of participants, data collection, and adherence to the study protocol, is important for the successful completion of the trial.

Data management: Effective data management is essential for the accuracy and integrity of study data.

Communication: Effective communication among team members, study participants, and regulatory authorities is important for the success of the trial.

1. Welcome Project management in clinical trials Banoth Vamshi B pharmacy CLS_053/032023 4/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 1

2. Index Project management plan Different activities and documents Creating a project management plan Protocol development 4/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 2

3. P roject management process 4/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 3

4. D ifferent activities/ documents 4/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 4 Regulatory Binder Protocol Investigator Brochure/Marketing Manual of Procedures Statistical Analysis Plan Statistical Analytic Protocol Data Safety and Monitoring Documents DSMB Report

5. Other… Meeting Templates Tracking / Monitoring Reports Data Quality Reports Additional Documentation 4/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 5

6. Creating a Project Management Plan A Project Management Plan is a document that results in a dynamic set of documents that clearly define the goals and provide direction for the project. The following tasks are critical to creating a project management plan: Define the project goals/deliverables/milestones Management using outline-based and/or graphical tools for calendars and schedules Management of internal and external communications Management of project personnel and responsibilities 4/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 6

7. Define project goals/ deliverables/ milestones The project goals, deliverables, and milestones are described in the trial protocol. The protocol should be the essential and controlling guide for the relevant protocol management activities. 4/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 7

8. Protocol development Activity Code Activity/ Deliverable Duration (days) Predecessor / Prerequisite A Draft Protocol 30 B Circulate Protocol Draft for Feedback and Input 14 A C Integrate changes 18 B D Circulate Draft Protocol for final Feedback and Input 14 C E Finalize Protocol 8 D 4/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 8

9. Manual of Operational Procedures In short it is also known as MOP The MOP is intended to serve as a study “cookbook”. The MOP facilitates adherence to study protocol, organizes the conduct of the study, and ensures consistency in research efforts throughout the study and across study sites. In theory, another investigator should be able to replicate the RCT’s conduct exactly as it was originally conducted by using the MOP. 4/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 9

10. 4/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 10  Clinical site management Pre-trial Execution Closeout Define sample size (Krishnankutty_2012) and recruitment strategies Review/ monitor data collection issues Complete final source data verification of Case Report Forms (CRFs/ eCRFs), ensuring protocol adherence, and managing the collection of final safety data Review site feasibility and qualifications for the study Define recruitment timeline Establish Site contact/ develop relationships with sites Keep an updated list of staff turnover for the sites Create site training and provision of study documents for the in-service presentation (i.e., Introductory letters/ handouts/ brochures/ HIPAA waivers) Re-in-service sites as often as needed (to keep momentum of the trial)

11. (Text here) 4/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 11 Recruit sites Monitor site (remotely or on-site) according to regulations Ensure all documentation (regulatory correspondence) is filed appropriately and ready for the clinical monitor or Clinical Research Associate (CRA) to review during the close-out visit Follow-up site with phone calls to administrators and track those communications in a log Hire/ Train/ Develop field staff Set meeting schedule for the staff Meet with staff weekly at first to problem solve. Then change to bi-weekly or monthly Develop site monitoring/Quality Assurance log Update log Define roles of study field staff vs. sites responsibilities Inform sites on performance and contractual issues Track problems/ issues and their resolutions Ensure return or destruction of all study related materials (i.e., unused lab kits and CRFs)

12. Common Pitfalls Lack of management follow-up and poor communications systems. Failure to submit amendments or keep up with study documentation updates. Not keeping up with staff certifications. Personnel turnover and a lack of redundancies buildup. Lack of compliance with regulations. Missing report deadlines due to a lack of organization in the calendar. Research site closures during the trial collection cycle. Unanticipated scope changes that affect the budget and schedule. Ineffective recruitment. Ineffective mechanism to maintain blinding. Ineffective use of technologies. Failure to update security systems. 4/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 12

13. Thank You! www.clinosol.com (India | Canada) 9121151622/623/624 [email protected] 4/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 13