This article provides a comprehensive guide for organizing and maintaining the Investigator Site File (ISF). The ISF is crucial for ensuring regulatory compliance and smooth conduct of the study. Here is a detailed breakdown of the sections and their contents:
Contact Information
1.1 Site Contact List: Includes contact details of site personnel.
1.2 CRO Contact List: Contact details of CRO (Contract Research Organization) representatives.
1.3 Sponsor Contact List: Contact details for sponsor contacts.
1.4 Third Party Contact List: Contact details of third-party organizations involved in the study.
Site Visit Documentation
2.1 Site Visit Log: A record of all site visits, including dates and purposes.
Study Communications
3.1 Correspondence with CRO: All correspondence with the CRO, filed in reverse chronological order.
3.2 Correspondence with Sponsor: Correspondence with the study sponsor.
3.3 Correspondence with Third Parties: Correspondence with third parties, excluding those related to the laboratory (filed in Section 12.3).
Site Personnel Details
4.1 Site Signature and Role Assignment List: A record of individuals authorized to perform specific tasks related to the study.
4.2 Principal Investigator Documents (CVs-Certificates): Updated CVs, signed and dated, and proof of required qualifications and/or medical licenses.
4.3 Sub-Investigator(s) Documents (CVs-Certificates): Similar documents for sub-investigators.
4.4 Other Relevant Site Personnel Documents: Qualifications and CVs of other staff members.
4.5 Training Records: Records of training completed by site personnel.
Volunteer Information
5.1 Volunteer Screening/Enrollment Log: Records of screened and enrolled volunteers.
5.2 Volunteer Visit Log: Records of all volunteer visits.
5.3 Volunteer Pre-Screening Log: Records of pre-screened volunteers for eligibility.
5.4 Blank Serious Adverse Event (SAE) Report Forms: Templates for reporting serious adverse events (SAEs).
5.5 Serious Adverse Event (SAE) Records: Records of all reported SAEs.
5.6 SAE Reports: Filed SAE reports.
5.7 Blank Pregnancy Reporting Forms: Templates for reporting pregnancies.
5.8 Protocol Deviation Log/Form: Forms for protocol deviations, signed and dated by the investigator.
Protocol and Amendments
6.1 Current Protocol / Amendment Protocol: The most recent approved protocol and amendments.
6.2 Protocol / Amendment Signature Pages and Acknowledgements: Signed pages for acknowledgment of receipt.
Approved Informed Consent Form (ICF)
7.1 Approved ICF and ICF Amendments: Approved informed consent form and amendments.
7.2 ICF Approval Letter: Approval letter from the ethics committee for ICF documents.
Ethics Committee Documents
8.1 Ethics Committee Approval Letter: Letter from the ethics committee confirming study approval.
8.2 Ethics Committee Communications: Correspondence with the ethics committee.
Training Documents
9.1 Principal Investigator Training Documents: Training documents for the principal investigator.
9.2 Sub-Investigator(s) Training Documents: Training documents for sub-investigators.
9.3 Other Staff Training Documents: Training documents for other site personnel.
Study Drugs and Supplies
10.1 Study Drugs and Supply Records: Records of drugs and supplies used during the study.
10.2 Drug Accountability Records: Records of drug calculations and checks.
Laboratory Documents
11.1 Laboratory Certifications: Certifications of laboratories used in the study.
11.2 Laboratory Normal Values: Normal value ranges for laboratory tests used during the study.
Other Study Materials/Equipment
12.1 Study Materials/Equipment Records:
Content: All materials sent to the site, such as thermometers, centrifuges, fax machines, etc.
Purpose: Documenting the receipt and inventory of study materials and equipment.
Guidelines: File the Study Material/Equipment Inventory Log and signed Clinical Trial Supplies Shipment Forms or Site Receipt Documents.
12.2 Equipment Calibration (Maintenance) Records:
Content: Records of equipment calibration and maintenance.
Purpose: Ensuring all equipment used in the study is properly calibrated and maintained.
Guidelines: The Site Equipment Calibration or Maintenance Log should be regularly filed and kept up-to-date.
Insurance Documents
13.1 Insurance Policy:
Content: Documents related to the insurance policy valid during the study.
Purpose: Documenting insurance coverage for the study.
Guidelines: Regularly check and keep the insurance policy documents updated.
13.2 Insurance Coverage Letters:
Content: Coverage letters from the insurance provider.
Purpose: Specifying details of insurance coverage.
Guidelines: Store these letters with the insurance policy documents.
Monitoring
14.1 Monitoring Visit Reports:
Content: Reports of monitoring visits conducted by the monitor.
Purpose: Documenting that monitoring visits are conducted regularly and findings are recorded.
Guidelines: File and track monitoring visit reports.
14.2 Monitoring Visit Communications:
Content: Correspondence and communications with the monitor.
Purpose: Keeping records of communication during the monitoring process.
Guidelines: File all correspondence in reverse chronological order.
Audits and Inspections
15.1 Audit and Inspection Reports:
Content: Reports related to audits and inspections.
Purpose: Documenting findings from audits and inspections.
Guidelines: Regularly file and track these reports.
15.2 Audit and Inspection Communications:
Content: Correspondence related to audits and inspections.
Purpose: Keeping records of communication during the audit process.
Guidelines: File all correspondence in reverse chronological order.
Study Results and Closure
16.1 Study Results Report:
Content: Results report prepared at the end of the study.
Purpose: Documenting the findings and results of the study.
Guidelines: File this report with all relevant documents.
16.2 Site Closure Report:
Content: Report indicating the completion of site closure.
Purpose: Documenting the end of the study and completion of all procedures.
Guidelines: Regularly update and file the closure report.
Other Documents
17.1 Relevant Other Documents:
Content: Other documents related to the study not mentioned above.
Purpose: Ensuring all additional study-related documents are properly stored.
Guidelines: Organize and file these documents by category.
This detailed list covers all necessary documents for the proper and organized maintenance of the Investigator Site File (ISF). The documents mentioned in each section will help ensure compliance with regulatory requirements at every stage of the study.
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