Study Implementation/ In-Service Training
After a study receives IRB approval, it is important to have a formal study implementation meeting with all internal key personnel. The focus of the implementation meeting is to ensure that all budget, contract, nursing, data collection, laboratory, and other protocol-specific issues have been resolved prior to opening a study to participant accrual. This is also the opportunity to ensure that all key personnel have completed any protocol specific training and are familiar with the expectations of the protocol and investigator responsibilities and the delegation of responsibilities.
The implementation meeting is a detailed planning session involving the key personnel associated with the study. Typical attendees of an implementation meeting include but are not limited to research staff (clinical research coordinators, clinical research nurses, data coordinators, clinical research managers and regulatory compliance officers, Principal Investigators and Sub-investigators), contract and budget analysts, clinical staff (clinic/unit nurse manager, nurse specialists, unit PCRM, clinic/unit staff RN), Pharmacist, clinic and research lab personnel, hospital administration, financial counselors and pre-certification/pre-determination representatives.
The agenda may include, but is not limited to, the items below:
- Key study personnel with contact information
- Study overview including objectives, design and purpose
- Participant eligibility and registration requirements
- Study specific tasks to be completed with timeline, feasibility and logistical requirements
- Investigational product management, storage, ordering and shipping requirements
- Required source documentation and examples of documentation tools
- Specific nursing or ancillary staff requirements
- Financial pre-determination or pre-certification considerations
- Data elements collected and timeline requirements for data submission
- SAE reporting guidelines
- Other processes or procedures that must be defined and implemented prior to enrolling study participants.
- FDA:21 CFR 312.60: Investigator Responsibilities http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.60
- FDA: 21 CFR 312.62 Investigator Record Keeping and Retention http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.62
- 1572 Statement of Investigator http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074728.pdf