11.1 Definition of terms
- Active Project file: refers to file pertaining to an ongoing study
- Completed file: refers to file pertaining to a completed study
- Master file: refers to file comprising of all essential documents and correspondence related to the study/protocol.
To provide guidelines for preparation and maintenance of active project files and other related documents approved by the IRB, CIHSR, and storing of closed files and retrieval of documents.
This SOP applies to both current and completed studies, approved by the IRB, CIHSR.
The IRB Secretariat will be responsible for ensuring that all study files are prepared, maintained, and kept securely for a period of five years after the closure of the project, while facilitating easy retrievals.
11.5 Maintenance of Active Study Files
- Create a master file comprising of all the essential documents and correspondence pertaining to the study/protocol, at the beginning of the trial, in the IRB secretariat
- A Unique Identifier (Ref. No. 001/2020/IRB_CIHSR) will be given to all studies approved by the IRB.
- All related documents of the approved study files will be gathered, classified, combined and filed appropriately
- All active study files will be kept in a secured cabinet with controlled access.
- 11.5.5. A log book of individuals accessing the files will be maintained by the IRB secretariat.
11.6. Maintenance of closed files
The study master files will be maintained separately in an easily accessible and secure place for a period of five years following closure of the study.
11.7. Accessibility/ Retrieval
- Master files will be made available for inspection and copying by authorized representatives of regulatory bodies after receiving a formal request in writing.
- A log book of authorized individuals accessing the files will be maintained by the IRB secretariat.
- In case, any investigator needs a copy of any document from the master file, he/she should make a written request to the IRB secretariat. The IRB Secretariat will issue a copy of the following documents on receipt of the formal written request:
- The research protocol
- The Informed consent
- The final data of the study
11.8. Disposal of closed files and copies of protocols and documents submitted for IRB review
- The closed files will be shredded and disposed of, on completion of the archival period of five years, without any further notification to the PI.
- The study protocols and other documents submitted for IRB review will be disposed of after the IRB meeting, without notification to the PI.
- A log book of disposed documents will be maintained. A soft copy of all disposed files will be maintained by the secretariat always.
11.9. Final disposal of Master Files
The master files will be permanently disposed of on completion of the archival period of five years. A register will be maintained, providing details of documents being written off / disposed of.