WHO publishes new Guideline for the preparation of a CRO Master File

With the revision of the WHO Technical Report Series No. 957 in June 2010, the WHO has also published a new Annex 7 "Guidelines for the preparation of a contract research organization master file". The complete report of the 44th WHO Expert Committee on Specifications for Pharmaceutical Preparations is also available as a WHO publication on the WHO website.

CROs will now be requested to submit a master file (similar to a site master file) to WHO, if a study was conducted at a site listed in a product dossier. CROMFs provide general information about the activities at a site. WHO inspectors will use them as background information during preparation and planning of inspections. They can also be a useful tool for national medicines regulatory authorities who conduct inspections at CROs.

A Contract Research Organization Master File (CROMF) is a document prepared by the Contract Research Organization (CRO) containing specific and factual information about the CRO and the conduct of clinical studies as well as the analyses of samples and related operations (including clinical trials, clinical data management, pharmacokinetics and statistical analysis and regulatory affairs) carried out at the named site. Annex 7 gives guidance on how to prepare such a CROMF.

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