Essential documents are the records that let someone else judge how a trial was run and whether its data can be trusted. This checklist arranges them the way the guideline does, by stage, with who holds each one, so you can track what is in place before enrolment, during conduct and at close-out.
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Before trial
14 of 16
During conduct
9 of 20
Overdue
2
Key points
How this differs from a file index
An index tells you which folder a document goes in. A checklist tells you whether you have the document yet and whether it is current. This page is the second kind. It follows the three stages of the guideline and shows who holds each item, so a sponsor can track the master file and an investigator can track the site file from the same list. For the folder structure of a site file, use the investigator site file index template. For setting up the sponsor file and its quality checks, read how to set up a trial master file.
The tables below are a working summary written for this page, not a reproduction of the guideline. The held-by column reflects the structure of ICH E6(R2) section 8. Confirm it against the official text and the version your regulator and sponsor apply before relying on it in an inspection.
Stage 1
Most of these should be in place before the first participant is screened. H = held by (I: investigator/institution, S: sponsor).
| Document | What it shows | H | Done when |
|---|---|---|---|
| Investigator brochure | Current scientific information on the product has been given to the investigator. | I, S | Current version on file with receipt date |
| Signed protocol and amendments, with sample CRF | Agreement to the protocol and the data to be collected. | I, S | Signature pages dated, CRF or eCRF specification attached |
| Information given to participants and consent form | What participants are told; translations where used. | I, S | Approved version and date match the approval |
| Advertisements for recruitment, if used | Recruitment material was approved. | I, S | Approved text on file |
| Financial aspects and insurance | Payment and compensation arrangements; insurance where required. | I, S | Contracts and certificates on file |
| Signed agreement between parties | Roles and responsibilities between investigator, sponsor and others. | I, S | Fully signed, dated |
| Ethics committee/IRB submission and approval | Favourable opinion for the protocol, consent form and updates. | I, S | Approval letter, composition or assurance as applicable |
| Regulatory authority authorisation or notification | The trial is permitted by the competent authority where required. | S (I where required) | Authorisation reference on file |
| Investigator and staff CVs and qualifications | The team is qualified to perform delegated tasks. | I, S | Signed and dated, current |
| Normal values and ranges for tests | Reference ranges for protocol-specified tests. | I, S | Current ranges, with dates |
| Laboratory and facility accreditation or certification | Test results can be relied on. | I, S | Certificates current for the whole trial |
| Product handling instructions and shipping records | How product is stored, handled and shipped. | I, S | Instructions filed, shipping records as generated |
| Sample label, decoding procedures and randomisation arrangements | Blinding can be maintained, and broken if needed. | S (I for site procedure) | Procedure in place and access restricted |
| Trial initiation monitoring report | The site was assessed and trained before starting. | I, S | Report filed and signed off |
| Delegation and training records | Who may do what, and that they are trained. | I, S | Delegation log signed and dated |
A summary for tracking. Add or remove rows based on your protocol and the relevance of each item.
Stage 2
These update as the trial runs. The test is "is the current version on file, and is the previous one kept?".
| Document | What it shows | H | Done when |
|---|---|---|---|
| Updates to the investigator brochure | New information reached the investigator. | I, S | Each version filed with receipt date |
| Revisions to protocol, consent form and recruitment material | Changes were approved before use. | I, S | Approval before implementation |
| Ongoing ethics committee/IRB approvals and notifications | Continuing review and reportable changes. | I, S | Letters in date order |
| Updated CVs, ranges, accreditations | Qualifications and reference data stay current. | I, S | Replacement filed when expired |
| Documentation of material and sample shipment | Chain of custody for samples and product. | I, S | Records for every shipment |
| Signed consent forms | Each participant consented before any trial procedure. | I | Original on file, copy to participant |
| Source documents | Original records of participant data. | I | Accessible and attributable |
| Completed CRFs and data corrections | Data entered and changes explained. | I (copy), S (original) | Corrections dated and justified |
| Notification of safety reports | Events and unexpected reactions were reported as required. | I, S | Reports and acknowledgements filed |
| Monitoring visit reports and follow-up | Oversight happened and findings were closed. | S (I copy of letters) | Report and response filed |
| Relevant communications other than visits | Decisions and agreements outside meetings. | I, S | Letters, emails, notes, filed |
| Screening and enrolment logs | Who was screened and enrolled. | I | Updated at each event |
| Product accountability at the site | Receipt, use and return of product. | I, S | Log reconciled at each visit |
| Signature sheet and delegation updates | Staff changes recorded. | I, S | Updated before new staff act |
| Records of retained samples | Where biological samples are held. | I, S | Location and disposition recorded |
See the [monitoring visit report template](/templates/monitoring-visit-report-template) and [delegation log template](/templates/delegation-log-template) for two of these records.
Stage 3
Close-out is where gaps become visible. Use this list at the close-out visit.
| Document | What it shows | H | Done when |
|---|---|---|---|
| Product accountability final reconciliation | All product is accounted for. | I, S | Final count signed |
| Documentation of product destruction | Unused product was returned or destroyed as agreed. | I, S | Certificate or return record on file |
| Completed participant identification code list | Records can be traced to participants, held confidentially. | I | Stored securely at the site |
| Audit certificate | Audit took place, where one was done. | S | Certificate on file |
| Final trial close-out monitoring report | Site closed out with no open items. | S | Report signed |
| Treatment allocation and decoding documentation | Allocation record returned to the sponsor. | S | Returned and locked |
| Final report to the ethics committee and authority | Required notifications were made. | I, S | Acknowledgement on file |
| Clinical study report | Results are reported. | S (I where required) | Final signed report |
| Archive and retention record | Where documents are kept and for how long. | I, S | Locations and periods recorded |
Retention periods come from local law and your sponsor agreement. See [data archiving and retention](/solutions/clinical-trial-data-archiving-retention).
A blank eCRF PDF, audit trail export and signed consent PDFs can be generated in the free sandbox, so you can see what you would file. Free sandbox, every feature, no credit card.
How to use it
One tab per stage, with columns for status, date filed, version, owner and notes. Add site and country columns if you run a multi-site file.
The guideline lets the list be reduced in advance by relevance. A note beside each removed row, signed off by the sponsor and QA, is better than a silent gap.
Device, imaging, pharmacy, DSMB, cell or gene therapy and local requirements will add documents the generic list lacks. Add your DSMB charter if you have one.
Agree a number of days from document completion to filing, and track lateness as a quality measure.
Compare the sponsor and site sets for the shared items: delegation, approvals, versions and dates should match.
Use it to find gaps while you can still fix them, rather than during an inspection.
R2 and R3
In Capture
Capture is an EDC, eCRF, ePRO, eConsent and randomization platform. It is not an eTMF and it does not hold your regulatory documents; see EDC vs eTMF and eTMF vs a shared drive. It does produce several records that appear in the lists above.
Blank eCRF · no subject data
Visit by form matrix
| Form | SCR | D1 | W2 | W4 | W8 | EOS |
|---|---|---|---|---|---|---|
| Demographics | X | |||||
| Vital signs | X | X | X | X | X | X |
| Laboratory | X | X | X | |||
| ECG | X | X |
3. Was the ECG performed?
☐ Yes☐ No
If No, complete question 4.
Quality check
Protocol, consent form and brochure on file match what sites use.
Dates of approval are earlier than implementation.
Delegation, agreements and reports signed.
CVs, certificates and laboratory ranges in date.
Shared items reconciled at monitoring visits.
Marked as superseded, not deleted.
Retrieve five random documents against the clock.
The location record is current for paper and electronic files.
Essential documents are the records that individually and collectively allow evaluation of how a trial was conducted and the quality of the data produced. They show that the investigator, sponsor and monitor complied with GCP and the applicable requirements.
By the stage at which they are normally generated: before the clinical phase begins, during the clinical conduct, and after completion or termination. Each item is marked as held by the investigator/institution, the sponsor, or both.
The sponsor keeps the trial master file, and each investigator keeps a site file. They overlap on shared documents such as approvals and delegation, and differ on documents only one party creates or needs.
ICH E6(R3), adopted in January 2025, uses the term essential records and replaces the stage lists with an essentiality test and a non-exhaustive table in an appendix. Check which version your regulator and sponsor apply to your trial.
The guideline allows the list to be supplemented, or reduced in advance, based on importance and relevance to the trial. Record the decision and get sponsor and QA agreement.
The data in an EDC are part of the trial record, and several exports from it belong in the file, such as the sample CRF, audit trail and consent PDFs. The EDC is not a replacement for the regulatory file.
No. Capture is not an eTMF. It produces data-side records such as the blank eCRF PDF, audit trail export and signed consent PDFs for you to file in your master or site file.
Keep exploring
Investigator site file index template
Folder structure for the site file.
How to set up a trial master file
The sponsor-side file.
eTMF vs a shared drive
Where to keep it.
ICH E6(R3) guide
Essential records and proportionality.
Delegation log template
A key shared record.
Good clinical practice (GCP)
The standard behind the list.
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