Initial R&D registration documentation

Please forward items 1, 2, and 3 (and 4, 5, and 6, if you have them) to kch-tr.research@nhs.net, clearly stating that you want the study to be put forward for R&D approval, and we will confirm receipt.

When our Research Governance Coordinators have carried out initial governance checks on your documents, they will email you to request any further items, signatures or clarification.

1. An unsigned version of the Integrated Research Application System (IRAS) R&D Application form A and B in pdf format. This form can be found on the IRAS website.

2. An unsigned Site Specific Information sheet (SSI) in pdf format. Send the SSI to the R&D Department even if your study is deemed site-specific exempt. Please add two additional boxes for extra signatories that may be required in section 23.

Contact the IRAS IT Helpdesk if you have any problems:
Tel 020 7099 2015
Email helpdesk@infonetica.net

3. A copy of your final agreed Protocol. An electronic copy of the dated and version controlled protocol you are submitting to ethics.

4. Peer review. Evidence of local peer review is required if your study has no funding. If it has funding or another organisation is the lead site, please provide evidence of peer review from these sources.

5. Ethics approval letter or the date of your ethics review.

6. Patient Information Sheet/Consent Forms. These should be on headed paper with local contact details. Please only send these at this initial stage if you have ethics approval. If you do not, we will request them as part of our governance checks.

Additional items that will be required

Letter of favourable opinion from the research Ethics Committee
You can submit to R&D prior to receiving ethics approval. However, a letter of favourable opinion will need to be received before the study can be fully approved.

Approved ethics documentation
Once you have been given your ethics approval, please provide us with the documentation it has agreed, on KCH headed paper with KCH local contact details on the Patient Information Sheet.

Authorisations on Site Specific Information Form (SSI) from the following:

  • Principle Investigator or Local Collaborator
  • Divisional Clinical Director & R&D Lead

Additional items that may be required

Sponsorship sign-off/letter
The Trust is willing, in principle, to sponsor studies initiated by its employees for work that will be carried out at KCH. If your study is not sponsored by KCH we will need a copy of a letter from the sponsor.

Honorary Contract/Research Passport/Letter of Access
If any of the research team will have direct contact with patients or identifiable patient data or tissue and are not employed by KCH an Honorary Contract/Research Passport or Letter of Access will be required. Please contact kch-tr.research@nhs.net for further information and the Research Passport forms and guidance.

Material Transfer Agreement
If tissue is being transferred between organisations, a Material Transfer Agreement (MTA) may be required.

Authorisations

  • If you are carrying out a device study you will need authorisation from Medical Engineering and Physics.
  • If radiation is involved you will need authorisation from the Radiation Department.
  • If your data will not be anonymised or pseudo-anonymised you will need authorisation from the Data Protection Officer.

Additional items that will be required if your study is a clinical trial involving a medicinal product (CTIMP)

  • MHRA ‘notice of acceptance’ letter
  • Clinical trial agreement between KCH and all external organisations
  • KCH Pharmacy authorisation
  • Proof of GCP training for all staff within last 18 months (see note below)
  • Proof of pharmacovigilence yraining (Chief Investigator of sponsor site only) is required where study is sponsored by King's College Hospital (see note below)

Please note: for all training needs, please go to the online booking form at the Joint Clinical Trials Unit (JCTO).

Additional items required if there is funding for the study

  • KCH Finance costing and sign-off
  • Details of costing in the Clinical Trial Agreement

Final R&D approval

Once all of the appropriate checks have taken place and you also have Ethics Approval, final R&D approval will be granted and you will be informed by letter and email by the department

Please note: there is special information if you are an Allied Health Professional

To ensure that your research projects are handled in an appropriate and timely manner, please check contact us to ensure you have the correct contact details for your enquiry.