Submission of Research Protocols to ISAC

Increase Font Size Decrease Font Size

All protocols must be submitted to the ISAC Secretariat using the ISAC Application form. Protocol requirements are broadly based on the International Society for Pharmacoepidemiology (ISPE) Good Pharmacoepidemiology Practices, and have been implemented to ensure that the issues considered essential for ISAC evaluation are covered in the protocol.

The current ISAC Application form includes a checklist on protocol content which must be completed prior to submission of the application. There are also additional questions to be completed on the experience and expertise available within the team undertaking the proposed research. Completed applications should be forwarded to the ISAC mailbox .

In order for a protocol to be considered valid and enter the ISAC assessment process, you must provide the information we require in this standard format and we will no longer consider protocols which have been prepared in other formats. Every application must have a chief investigator (CI) who is a senior person who takes responsibility for the research and signs the application. There must also be a corresponding applicant (who can be the CI) to directly deal with the ISAC Secretariat. It will not be acceptable for persons not involved in the protocol application to communicate with the Secretariat.

A brief Curriculum Vitae vitae in a standard format must be provided for each applicant; although it will only be necessary to submit this once (unless an update is needed). The Secretariat will provide a reference number for use in future applications. A conflict of interest statement covering all the applicants must also be provided.

Links to:



ISAC Guidance on the Content of Protocols for research using CPRD data

Role of ISAC

The full remit of ISAC is stated here. The purpose of the Committee's review of ISAC protocols is to ensure that investigators using the databases for research have viable plans which do not raise governance concerns and reach an acceptable scientific standard. We aim to provide timely, high quality peer review of protocols whilst recognising that the quality of the research ultimately remains the responsibility of the applicants.

This guidance is intended to identify issues that are essential for ISAC's scientific evaluation of the proposed research. We welcome feedback from researchers on the guidance.

When planning a study, applicants should search the CPRD bibliography for related publications derived from the database and are encouraged to contact the CPRD Knowledge Centre () to identify any similar studies, particularly those addressing the same research questions with the same data. Applicants are encouraged to take into account potential duplication of effort at the planning stage and to give priority to novel research questions

Prior to developing the protocol, it is suggested that applicants consult with the ISAC Secretariat regardingthe feasibility of the proposed research. This may be particularly important for researchers with limited experience of either the CPRD or of UK primary or secondary health care.

When submitting your protocol to ISAC, you will be required to complete the ISAC application form and incorporated checklist to confirm that you have covered the issues identified in these instructions; protocols that do not comply will be returned to investigators.



Points to remember

Please:

  1. Be succinct. You should aim for 5 - 10 pages of A4 long (single spaced), excluding annexes.
  2. Use annexes to list the codes to be used for the definition of exposure(s) and outcome(s).
  3. Number the pages; numbering of sections may also be useful.
  4. Ensure that all named collaborators have received copies of the application.