ICH E6(R3) states that, before a trial starts, the investigator or institution should have a documented and dated agreement with the sponsor, and that the financial aspects of the trial should be documented in an agreement between them (ICH E6(R3), EMA Step 5). Those agreements are essential records, and in the EU the trial master file must contain the essential documents at all times and be kept for at least 25 years after the trial ends (EMA TMF guideline).
In many organisations, the finance team works from one copy of an agreement and the TMF holds another. Amendments are signed and used for payments, but reach the TMF weeks later, or not at all. When an inspector asks which version of a site agreement was in force on a given date, the answer depends on two systems agreeing.
Which financial records belong in the TMF
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Record
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Why it matters
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Rule behind it
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Executed site agreements, including budgets
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Shows the financial aspects were agreed before the trial started
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ICH E6(R3)
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Agreement amendments
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Shows which terms applied, and from when
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ICH E6(R3), EU TMF guideline
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Agreements with CROs and vendors
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Shows which duties were transferred
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ICH E6(R3) section 3.6
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Investigator financial disclosure (US)
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Required before investigators take part, and for marketing applications
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21 CFR 312.53 and Part 54
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Participant compensation arrangements
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Part of what ethics committees and regulators approve
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EU Clinical Trials Regulation, Annex I
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What happens when CTFM and eTMF are separate
- Version gaps. Payments are made under an amendment that is not yet in the TMF.
- Late filing. Executed agreements are filed in batches before audits, not when they are signed.
- Duplicate work. The same document is uploaded to the finance system and again to the TMF.
- Inspection risk. Agreement and activation dates cannot be checked against each other easily.
What changes when they share one platform
1. One executed version. The agreement finance pays against is the same one filed in the TMF.
2. Filed when signed. Executed agreements and amendments can be filed to the TMF as they are executed, which supports TMF timeliness as well as completeness.
3. Terms and documents linked. The budget lines and payment terms in CTFM sit next to the document that set them, so anyone can see where a number came from.
4. Activation backed by evidence. When a site is activated, the executed agreement is already in the TMF, so the record shows it came first.
5. One audit trail. Changes to the agreement, the budget and the filed document are recorded together.
Checklist
- Every executed site, CRO and vendor agreement filed in the TMF
- Agreement amendments filed with dates and versions
- The agreement used for payments matches the TMF version
- US financial disclosure forms filed before investigators take part
- Agreement execution dates checked against site activation dates
- One person or team owns financial records in the TMF plan
What this means by role
- eTMF managers: financial essential records arrive in the TMF as they are signed, not before an audit.
- Study finance teams: you pay against the same version the TMF holds.
- QA and compliance directors: agreement versions, dates and payments can be traced together.
- Clinical operations directors: activation decisions are backed by filed agreements.
How Cloudbyz CTFM and eTMF work together
Cloudbyz CTFM and Cloudbyz eTMF are built natively on Salesforce as one platform, together with Cloudbyz CTMS. CTFM tracks site, CRO and vendor agreements and their amendments, and holds the budgets and payment terms they set. Because eTMF is on the same platform, executed agreements and amendments can be filed to the TMF with their metadata and audit trail, without a separate upload, and finance and the TMF work from the same version.
See CTFM and eTMF together
Book a demo or visit cloudbyz.com.
