Integrated Research Application System (IRAS)

Checklist for REC Form – CTIMP

Document Title / Can Add Row / Enclosed Type / Date / Version
Covering letter on headed paper / No / Yes/No / Yes / No
REC application (IRAS Parts A-D) (signed copy) / No / Mandatory / Yes / Yes
Site-Specific Information Form (if main REC is also the SSA REC for a trial site) (signed copy) / Yes / Yes/No / Yes / Yes
Research protocol (6 copies) / No / Mandatory / Yes / Yes
Investigator’s brochure (3 copies) / Yes / Yes/No / Yes / Yes
Summary CV for Chief Investigator (CI) / No / Mandatory / Yes / No
Research participant information sheet (PIS) / Yes / Mandatory / Yes / Yes
Research participant consent form / Yes / Mandatory / Yes / Yes
Letters of invitation to participant / Yes / Yes/No / Yes / Yes
GP/consultant information sheets or letters / Yes / Yes/No / Yes / Yes
Evidence of insurance or indemnity (non-NHS sponsors only) / No / Mandatory / Yes / No
Letter from sponsor / No / Yes/No / Yes / No
Letter from statistician / No / Yes/No / Yes / No
Referees? or other scientific critique report / Yes / Yes/No / Yes / No
Summary, synopsis or diagram (flowchart) of protocol in non-technical language / Yes / Yes/No / Yes / Yes
Details of any Data Monitoring Committee / No / Yes/No / Yes / Yes
Sample diary card/patient card / Yes / Yes/No / Yes / Yes
Validated questionnaire / Yes / Yes/No / No / No
Non-validated questionnaire / Yes / Yes/No / Yes / Yes
Copies of advertisement material for research participants, e.g. posters, newspaper adverts, website. For video or audio cassettes, please also provide the printed script. / Yes / Yes/No / Yes / Yes
Covering letter on headed paper / No / Yes/No / Yes / No
REC application (IRAS Parts A-D) (signed copy) / No / Mandatory / Yes / Yes
Site-Specific Information Form (if main REC is also the SSA REC for a trial site) (signed copy) / Yes / Yes/No / Yes / Yes
Research protocol (6 copies) / No / Mandatory / Yes / Yes
Investigator’s brochure (3 copies) / Yes / Yes/No / Yes / Yes
Summary CV for Chief Investigator (CI) / No / Mandatory / Yes / No
Research participant information sheet (PIS) / Yes / Mandatory / Yes / Yes
Research participant consent form / Yes / Mandatory / Yes / Yes
Letters of invitation to participant / Yes / Yes/No / Yes / Yes
GP/consultant information sheets or letters / Yes / Yes/No / Yes / Yes
Evidence of insurance or indemnity (non-NHS sponsors only) / No / Mandatory / Yes / No
Letter from sponsor / No / Yes/No / Yes / No
Letter from statistician / No / Yes/No / Yes / No
Referees? or other scientific critique report / Yes / Yes/No / Yes / No
Summary, synopsis or diagram (flowchart) of protocol in non-technical language / Yes / Yes/No / Yes / Yes
Details of any Data Monitoring Committee / No / Yes/No / Yes / Yes
Sample diary card/patient card / Yes / Yes/No / Yes / Yes
Validated questionnaire / Yes / Yes/No / No / No
Non-validated questionnaire / Yes / Yes/No / Yes / Yes
Copies of advertisement material for research participants, e.g. posters, newspaper adverts, website. For video or audio cassettes, please also provide the printed script. / Yes / Yes/No / Yes / Yes