Sponsor responsibilities for writing and maintaining essential documents required for Clinical Trial Authorisation applications

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)) and the investigational medicinal product dossier when available.

Protocol sections related to IMP management include but are not restricted to:

  • inclusion/exclusion criteria
  • IMP section
  • 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)

The sponsor pharmacy should liaise with the IMP 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.

Currency of content

The IMP supply chain may include several manufacturers or vendors. It is a sponsor responsibility to ensure the IMPD remains 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

Substantial amendments to IMPD or other submitted documents must be submitted for regulatory approval by Sponsor. An amendment tool is available via IRAS to assist Sponsors in determining the classification of changes.

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.

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.

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