Deconstructing all types of monitoring visits
Download as PPTX, PDF3 likes1,002 views
There are four types of monitoring visits for clinical trials: site selection visits, site initiation visits, interim monitoring visits, and close out visits. Site selection visits involve touring facility and assessing capabilities. Site initiation visits focus on training, delegation, supply receipt, and system access. Interim monitoring visits review protocol compliance, safety reporting, data verification, and recruitment. Close out visits include reconciling supplies, closing safety reports, finalizing data, and archiving documents.
Deconstructing all types of monitoring visits
- 1. Deconstructing All Types of Monitoring Visits
- 2. COV There are 4 types of monitoring visits. 2 IMV Interim Monitoring Visits SSV Site Selection Visits SIV Site Initiation Visits Close Out Visits
- 3. SITE SELECTION VISITS TOUR OF FACILITIES SHOULD INCLUDE: ◂ IP Storage ◂ Monitoring Space ◂ Storage of site files ◂ Lab and calibrations Main Objectives: ◂ Assess site capabilities ◂ Enrollment projections ◂ Experience of staff ◂ Tour of facilities ◂ Informed consent SOPs ◂ Study specific SOPs 3
- 4. SITE INITIATION VISITS TRAINING AND DELEGATIONS ◂ Make sure all research staff is trained on study protocol ◂ GCP should be filed ◂ Complete delegation log Main Objective: Site Activation ◂ Is the site ready to screen patients? ◂ If not, all pending tasks become action items 4 CONFIRMING RECEIPT OF SUPPLIES ◂ Lab kits ◂ Study drug ◂ ECG machines ◂ Study specific equipment ◂ Source documents ASSIGNING STUDY ACCESS Make sure pertinent staff has: ◂ EDC access ◂ IWRS access ◂ Lab/ECG portal access ◂ Study specific portal access
- 5. CLOSE OUT VISITS IP RECONCILIATION ◂ Make sure all research staff is trained on study protocol ◂ GCP should be filed ◂ Complete delegation log Main Objective: Site Activation ◂ Is the site ready to screen patients? ◂ If not, all pending tasks become action items 5 CONFIRMING RECEIPT OF SUPPLIES ◂ Lab kits ◂ Study drug ◂ ECG machines ◂ Study specific equipment ◂ Source documents CLOSE OUT SAEs Make sure pertinent staff has: ◂ EDC access ◂ IWRS access ◂ Lab/ECG portal access ◂ Study specific portal access
- 6. INTERIM MONITORING VISITS PROTOCOL DEVIATIONS Make sure PDs are reported properly and corrective action plans or retraining is done accordingly Every IMV will be different, even for the same study, depending on what is required at each site. 6 AEs/SAEs Ensure that SAEs are reported within 24 hours and follow up SAE reports are completed. SDV/SDR Make sure that source data matches what is entered in EDC, and follows ALCOA Issue queries in EDC where there are discrepancies or missing data RECRUITMENT Some sites may struggle with recruitment, issues may be discussed
- 7. INTERIM MONITORING VISITS REGULATORY MAINTENANCE Make sure delegation log and training logs reflect any added/discontinued staff Ensure that IRB approvals, correspondence, safety reports, enrollment logs, and newsletters are filed. Make sure all medical licenses are up to date and all staff is trained on protocol amendments. 7 DRUG ACCOUNTABILITY Make sure all drug shipping documents are filed, temperature logs have no excursions, and accountability is done accurately with no discrepancies. Check for expirations. MEET WITH THE PI Discuss overall conduct of site, action items, and ensure there is PI oversight
- 8. INTERIM MONITORING VISITS INFORMED CONSENT Make sure all screened subjects have signed informed consent, and that ICF process has been properly documented 8 SCREEN FAILURES Identify reasons for screen failures and make sure that subjects were screen failed for legitimate reasons ELIGIBILITY Ensure that all randomized subjects meet eligibility criteria and medical records are filed to validate inclusion/exclusion criteria
- 9. CLOSE OUT VISITS RETURNING OF STUDY SUPPLIES ◂ ECG ◂ Lab kits ◂ Study drug ◂ Study specific equipment (tablets, laptops, diaries, etc) Main Objectives: ◂ IP reconciliation ◂ Close out SAEs ◂ Ensure SUSARs are signed/filed ◂ End dates for everyone on DAL ◂ Returning of study supplies ◂ Finalize EDC, signed off by PI ◂ Study document archival ◂ IRB close out report 9
- 10. COV Monitoring reports and letters for all visits: 10 IMV Monitoring report submitted after visit SSV Schedule visits with sites SIV Confirmation letter to site prior to visit Follow up letter to site after visit with action items