Clinical Trial Protocol
The Sponsor Lead pharmacist must write/review the IMP related sections of the protocol for safety and integrity of the research purpose. This must be done by cross-checking with the safety reference document available (Investigator Brochure (IB) or Summary or Product Characteristics (SmPC)) the investigational medicinal product dossier and the non-investigational medicinal product dossier when available. For NIMPs and IMPs a simplified dossier is accepted for authorised and unmodified medicinal products.
Protocol sections related to IMP management include but are not restricted to:
- inclusion/exclusion criteria
- IMP section
- NIMP section when available
- concomitant medication
- supportive medications
- side effects, pharmacovigilance
- blinding procedure
- IMP supplies
- IMP related quality management
Other mandatory submission documentation
Depending on local facilities and experience, Sponsor pharmacy staff should be able to create or advise on other critical documents for the CTIMP application such as IB, Pharmacy Manual documentation and information entered into the Combined Review application.
Investigational medicinal product dossier (IMPD) and non-investigational medicinal product dossier (NIMPD)
The sponsor pharmacy should liaise with the IMP (and NIMP when applicable) manufacturer where there is an IMPD required for the regulatory submission. This is to ensure its accuracy and that it is agreed collaboratively. The content of the IMPD is ultimately a Sponsor responsibility.
Non-investigational medicinal products do not necessarily require their own dossier (although a simplified dossier format may be used if desired) but must, as a minimum, be listed in the cover letter and also included in an IMP dossier annex with information about their properties, labelling, manufacture, stability and safety controls, as appropriate to the product when used at the intended maximum dose/dosing frequency and route of administration.
Currency of content
The IMP (and NIMP when applicable) supply chain may include several manufacturers or vendors. It is a sponsor responsibility to ensure the IMPD and NIMPD remain accurate, and is updated as changes are required, and that any changes are communicated to the relevant parties as required by the technical agreement(s).
Amending the IMPD and NIMPD
Substantial modifications to IMPD or other submitted documents must be submitted by the Sponsor via route A or route B for regulatory approval. A modification tool has been published by the MHRA to assist Sponsors in determining their classification.
Quality Technical Agreements
The Sponsor must have appropriate Quality Technical Agreements with the relevant providers. These will detail which organisations have responsibility for the activities supporting Good Manufacturing Practice (GMP) and GCP for the IMP during the conduct of the trial. Consideration must be given to the location of the Qualified Person (QP) certifying the product to ensure the supply chain complies with the regulatory changes regarding EU Exit (SPS page).
Patient Facing Documentation (PFD)
Patient Facing Documentation (PFD) includes resources such as patient information sheet, patient alert cards and medication diaries.
Prior to the submission of the ethics application, the Sponsor Lead Pharmacist must review the PFD related to the IMP for accuracy of the information provided to the participants.
IMP, treatment, concomitant medications, side effects and post-trial IMP access must be reviewed, cross checking with the protocol.
Supporting information
MHRA – Medicines: Clinical trials hub
MHRA – Clinical trials for medicines: modifying a clinical trial approval
Update history
- Updated in line with amendments to clinical trials regulations.
- Published