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 | Monitoring Services » Monitoring |
Site Qualification Visit:
Site qualification visits to check:
- Hospital infrastructure
- Resources
- ICH-GCP trained staff
- Availability of laboratory/ radiological and imaging facilities
- EDC facility
Site Initiation Visit
Site initiation visit to confirm:
- Attendance of all team members
- That the team has received and read the study-related material
- The PI is prepared to discuss delegation of tasks
- The team members are prepared on:
- Reporting of AEs/SAEs
- Regulations/Guidelines
- Inclusion/exclusion criteria
- Check that the procedures and plans for storage, dispensing and return of study medication have been agreed and finalized with the sponsor and pharmacy.
- Involves a detailed discussion of the type of subject/patient to be recruited, the completion of the CRF and administrative procedures to be followed.
- In addition, evaluation of the Investigator\\\'s understanding of the protocol, his/her obligations during the study and the likely recruitment rate are also be discussed and agreed.
Interim Monitoring Visit
The following issues are addressed at each interim visit as appropriate:
- Informed consent process
- Source document verification 100%
- CRF completion
- Expedient data retrieval and query resolution
- Drug accountability
- Check and review of the regulatory binder and its contents
- Clinical supply inventory
- SAE reporting
- Enrolment issues and targets
- Protocol amendments
- Significant protocol deviations
- Acceptability of facilities
- Personnel changes
- Updated regulatory documentation
- Laboratory sample handling
- Any other issue as deemed important to the conduct of the study
- The investigator is carrying out the agreed-upon activities and has not delegated them to other previously unspecified staff.
Study Close-Out Visit:
The study close-out activities of a clinical research protocol are as important to complete as the initial approval and study start up process. At the completion of the study the Principal Investigator is responsible for ensuring the appropriate close-out activities are completed and the proper institutional offices are notified.
During the Close out of a trial, following issues are addressed
- Completion of study records
- Reconciliation and inventory of study supplies
- Notify institutional regulatory offices
- Proper record retention of study documentation
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