Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.5: Difference between revisions
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| | |has_document=Document:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 | ||
| | |module=2 | ||
| | |unit=2.1.2 | ||
| | |scope=HM | ||
| | |doc_part=4.5 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
|tags=TAG-00152-Tri-gat ++ TAG-00343-Doc-ten ++ TAG-00149-Sig-nds ++ TAG-00060-Del-ben ++ TAG-00327-Exa-spi | |||
|tags_display=[[Glossary:TAG-00152-Tri-gat|Trial master file]], [[Glossary:TAG-00343-Doc-ten|Documentation]], [[Glossary:TAG-00149-Sig-nds|Signature]], [[Glossary:TAG-00060-Del-ben|Delegation]], [[Glossary:TAG-00327-Exa-spi|Examples]] | |||
|comment=TMF content and risk-adaptation examples | |||
|content=4.5. Trial documentation | |||
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4.5. Trial documentation | |||
Content of the Trial Master File (TMF) | Content of the Trial Master File (TMF) | ||
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o IMP related documentation: IMPs with a marketing authorisation and supplied to the patients via a routine medicines supply chain (i.e. from the pharmacy, based on a medical prescription) may not require any additional accountability records or only limited recording of consumption of the IMP e.g. in the CRF or patient diary. Therefore, the following documents may not be needed to be included in the TMF: instructions for handling, shipping records, certificates of analysis of IMPs or trial-related materials, drug accountability documentation (see also Section 4.3), destruction documentation, temperature monitoring records (if the IMP is used as per normal clinical practice and stored in the usual place, for those that do not have temperature monitoring – e.g. ambient storage in hospital theatre), sample of labels as these may just be the normal hospital dispensing label, | o IMP related documentation: IMPs with a marketing authorisation and supplied to the patients via a routine medicines supply chain (i.e. from the pharmacy, based on a medical prescription) may not require any additional accountability records or only limited recording of consumption of the IMP e.g. in the CRF or patient diary. Therefore, the following documents may not be needed to be included in the TMF: instructions for handling, shipping records, certificates of analysis of IMPs or trial-related materials, drug accountability documentation (see also Section 4.3), destruction documentation, temperature monitoring records (if the IMP is used as per normal clinical practice and stored in the usual place, for those that do not have temperature monitoring – e.g. ambient storage in hospital theatre), sample of labels as these may just be the normal hospital dispensing label, | ||
o hospital laboratory accreditation certificates and reference ranges (when these laboratories are not providing information that is critical to the reliability of the trial results). | o hospital laboratory accreditation certificates and reference ranges (when these laboratories are not providing information that is critical to the reliability of the trial results). | ||
}} | |||
Latest revision as of 13:49, 16 July 2026
| Document information | |
|---|---|
| Reference | EU Recommendations of the expert group -
Risk proportionate approaches in clinical trials 25-Apr-2017 |
| Validity area | EU |
| Scope(s) | HM |
| Document name | Recommendations of the expert group -
Risk proportionate approaches in clinical trials |
| Version / Revision | 25-Apr-2017 |
| Status | Current |
| Document type | Official recommendation |
| Language(s) | EN |
| Description | Risk proportionate approaches in clinical trials
Recommendations of the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 2 — Unit 2.1.2 |
| Scope | HM |
| Document part | 4.5 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Trial master file, Documentation, Signature, Delegation, Examples |
Content
4.5. Trial documentation Content of the Trial Master File (TMF) […] Examples of how risk-adaptation could affect the TMF include the following: - combining of documents: one document serves multiple purposes (screening logs and recruitment logs, signature and delegation logs, site assessment and site initiation etc.), - absence of documents, as a result of implementation of other risk proportionate measures, for example:
o Investigator Brochure as the Summary of Product Characteristics is being used instead, o Clinical Study Report may be absent as it is replaced by a medical journal publication, o IMP related documentation: IMPs with a marketing authorisation and supplied to the patients via a routine medicines supply chain (i.e. from the pharmacy, based on a medical prescription) may not require any additional accountability records or only limited recording of consumption of the IMP e.g. in the CRF or patient diary. Therefore, the following documents may not be needed to be included in the TMF: instructions for handling, shipping records, certificates of analysis of IMPs or trial-related materials, drug accountability documentation (see also Section 4.3), destruction documentation, temperature monitoring records (if the IMP is used as per normal clinical practice and stored in the usual place, for those that do not have temperature monitoring – e.g. ambient storage in hospital theatre), sample of labels as these may just be the normal hospital dispensing label, o hospital laboratory accreditation certificates and reference ranges (when these laboratories are not providing information that is critical to the reliability of the trial results).
