Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.5

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
Scope	HM
Document part	4.5
Language	EN
Original entry by	Florian Adragna
Contributors
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Tags (FR)
Comment	TMF content and risk-adaptation 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).