Guidelines for the preparation of a contract research organization master file
Background:
A contract research organization master fi le (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. If only some of the operations referred to below are carried out at the site, the master file (MF) needs to be presented only for those operations.
In a case where a CRO is responsible for activities pertaining only to bioanalytical procedures, then only sections in the CROMF relating to these should be described. Other sections may be marked as “not applicable”.
Where a CRO performs various activities, separate sections could be prepared for the different units, e.g. clinical pharmacology unit (CPU) and bioanalytical laboratory (BAL).
A CROMF provides information on the policies, approach and general activities of a CRO. It is not trial-specific as trial-specific data are submitted in a product dossier. It serves as general information to regulators and can be used during preparation for inspections by regulatory inspectors in addition to the trial-specific data and information submitted for assessment. It also provides an overview of the organization’s approach to good clinical practices (GCP), good laboratory practices (GLP) and other guidelines pertaining to its activities.
A CROMF should be submitted to the national medicines regulatory authority (NMRA) where such a document is requested. It should be succinct and as far as possible not exceed 25 A4 pages (where appropriate, supportive documentation may be appended).
An updated CROMF should be submitted when requested by the NMRA, or if significant changes have been implemented by the CRO.
See pdf file for complete details:
WHO TRS (Technical Report Series) 957, 2010 Annex 7:
