The ISF is where a site keeps the documents that show the trial was run to protocol and GCP. This index gives you a 13-folder structure based on the ICH E6 essential documents, with when each item is filed and which records Capture can export for it.
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Protocol and amendments
Ethics committee / IRB
Approval letter v2 filed
Informed consent
Version 3 pending approval
Investigator and staff
Investigational product
Monitoring and correspondence
Key points
What it is
The ISF has one job: to let someone who was not there, such as a monitor, auditor or inspector, reconstruct what the site did and prove it was authorised to do it. Every document either shows permission (ethics approval, regulatory authorisation, signed agreement), qualification (CVs, training, licences), consent (approved forms and signed originals), control of the product (accountability, storage), safety handling (SAE reports and sponsor notifications), or oversight (monitoring and correspondence).
Sponsors usually supply a site binder or electronic folder structure at site initiation, and that structure takes precedence. The index below is a neutral starting point for investigator-initiated studies or for checking a sponsor's structure against ICH E6. For the sponsor-side master file and how it differs from the data system, see EDC versus eTMF; for what inspectors look at in the data itself, see the FDA inspection checklist.
File documents as they are generated, with dates and signatures, and keep superseded versions with the date they were replaced. A site file assembled just before a monitoring visit usually shows gaps that cannot be repaired, such as a delegation log signed after the person started work.
Medical records and participant-level source usually stay in the clinical record, with the ISF holding the screening and enrolment logs and a note of where source is kept. Confidential participant identification lists stay locked, apart from the study data.
Folders complete
9 of 13
Expiring within 60 days
2
Template
| # | Folder | Typical contents | Filed |
|---|---|---|---|
| 1 | Protocol and amendments | Signed protocol and signature page; each amendment; sample CRF or eCRF specification | Before, then on change |
| 2 | Investigator's brochure and product information | Current brochure or product information and each update | Before, then on update |
| 3 | Ethics committee or IRB | Submissions, approval letters, approved participant materials, committee composition, continuing review | Before, then during |
| 4 | Regulatory authority | Authorisation or notification where required, with correspondence | Before, then during |
| 5 | Informed consent | Approved consent forms by version and language, signed originals, record of consent process | Before, then during |
| 6 | Investigator and staff | Signed CVs, licences, GCP training, delegation log, signature specimen sheet | Before, then on staff change |
| 7 | Agreements | Clinical trial agreement, financial agreement, insurance and indemnity statements | Before |
| 8 | Laboratory and facilities | Normal ranges, laboratory accreditation, equipment calibration records | Before, then on update |
| 9 | Investigational product | Shipment records, accountability log, storage temperature records, returns and destruction, instructions for handling | During, then after |
| 10 | Safety reporting | SAE reports, sponsor safety notifications, annual safety reports sent to the committee | During |
| 11 | Participant records | Screening and enrolment logs, participant identification list (confidential), CRF or eCRF access records | During |
| 12 | Monitoring and correspondence | Monitoring visit log, follow-up letters, notes to file, relevant emails and calls | During |
| 13 | Close-out | Final product reconciliation, completion notification to the committee, archiving record, final report | After |
Based on the ICH E6(R2) section 8 essential documents list. Your sponsor's file plan may number and group items differently; follow it where one exists.
What Capture can produce
Capture is the EDC, not a document management system, so it does not replace the ISF. It does produce several records that sites and sponsors file in it, and it keeps the data side of inspection readiness in one audit trail.
| SUBJ | ECGPERF_CODE | ECGPERF_LABEL |
|---|---|---|
| 01-001 | Y | Yes |
| 01-002 | ND | Not done |
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How to use it
Use the sponsor's file plan if there is one. Otherwise adopt the 13 folders above and record the structure as the first page of the file.
Create the folders and file approvals and agreements as they arrive, so the file is complete before the first participant is screened.
One line per document: version, date, location, status. Review it at every monitoring visit.
Date everything and file within days. Late filing is the most common finding in site audits.
Licences, GCP certificates and laboratory accreditations expire. Add review dates to the index.
Reconcile product, notify the committee, and archive for the retention period required by the regulator and sponsor. Record where the file is stored.
Before the first participant
Ethics approval and any regulatory authorisation cover the protocol and consent version in use.
Delegation log signed before tasks start, with GCP training and CVs for everyone on it. See the delegation log template.
Only the approved version is available at the site, and superseded versions are retained.
Clinical trial and financial agreements and insurance statements filed.
Screening and enrolment, product accountability and temperature logs ready. See the screening and enrolment log.
Know where SAE reports and sponsor notifications are filed, and see the SAE report form.
The investigator or institution's collection of essential documents for a trial: approvals, protocol, signed consents, staff records, agreements, product accountability, safety reports and correspondence. It shows the trial was conducted according to the protocol and GCP.
The ISF is the site's file. The trial master file is the sponsor's file. Each holds its own copy of the essential documents, and some documents appear in both.
Section 8 of ICH E6(R2), organised by when documents are generated: before the clinical phase, during it and after completion. ICH E6(R3) refers to essential records, so confirm which version applies to your study.
Yes, if the system provides access controls, an audit trail and reliable copies, and the sponsor and regulator accept it. Capture is not a document management system and does not hold the ISF.
For the period set by the applicable regulations and the sponsor, which can be many years after the trial ends. Confirm the retention period with the sponsor and record the archive location.
A blank eCRF PDF, signed consent PDFs with signature data and audit trail, and data exports with a data dictionary and export log. These support folders such as protocol materials, consent and monitoring.
Audit trail, signed consent exports and blank eCRF PDFs in one system. Free sandbox.