Clinical Study Closeout Program
Overview:
Database lock & study closure procedures often brings to mind anxiety and high stress moments for many clinical research professional. With this webinar, we will arm the audience with knowledge, tools, and strategies to alleviate such emotions.
This webinar will provide initially provide information basic study closure procedures. Then, we will discuss a more comprehensive list of closure procedures. Lastly, we provide strategies to make the process run effectively and efficiently.
The term "close-out" refers to procedures undertaken to fulfill administrative, regulatory, and human participant requirements. Study close-out may be also defined as the time when all participant visits have been completed, data base has been locked, and all lab specimens are accounted for/reconciled. The period leading to study closure activities often invokes high-stress, anxiety emotions from many clinical research professionals.
Areas Covered in the Session:
- Preparing for study close-out visit from various perspectives (e.g., DM, PM, CRC, CRA perspectives)
- Managing study close-out visit
- Sponsor's Responsibilities
- Disposition of supply of investigational products
- Assurance of IRB review
- Investigator recordkeeping & archiving/record retention
- Inspection of investigator's records & reports
- Quality Assurance Responsibilities
- Data Review Meetings
- Proactive Vendor Management
- Financial/Accounting Reconciliations
- Regulatory Obligations (Sponsor & Site)
Who Will Benefit:
- CRAs
- CRCs
- Nurses
- Clinical Trials Associates
- Regulatory Affairs
- Clinical Team Managers
- Clinical Trials Project Managers