Information Regarding Commercially Sponsored Studies
The Commercial Team in NHS Grampian Research and Development Office are responsible for overseeing all aspects of commercial sponsored research undertaken within our Health Board.
Feasibility requests
Please include R&D in any approaches to Investigators in Grampian at the earliest opportunity. You can do this by using the NHS Research Scotland (NRS) Feasibility Service - https://www.nhsresearchscotland.com/industry/study-pathway/feasibility
Or by copying in our feasibility team – gram.randdfeasibility@nhs.scot
Note that review/signing of study specific CDAs must be undertaken by the feasibility team/Head of Commercial services and not the PI. We recommend use of the model CDA which is available at https://www.myresearchproject.org.uk/help/hlptemplatesfor.aspx#mCDA
Alternatively the NRS Feasibility Service is able to arrange for a Master CDA for all sites in Scotland.
Site Selection Visits (SSV)
Our feasibility team can help arrange the SSV once our site has shown interest in study. Please include them in any correspondence.
Submission of documents for review:
Documents for R&D submission are submitted via IRAS. PLEASE ENSURE SCOTLAND IS SELECTED in the filter questions. NHS Research Scotland Permission Co-ordinating Centre (NRS PCC) will then be able to download the documents to our Scottish database and inform participating sites.
Information about including Scottish sites can be found here: https://www.myresearchproject.org.uk/help/hlpnhshscr.aspx#scotland
PLEASE DO NOT SEND DOCUMENTS DIRECTLY TO THE R&D OFFICE.
R&D approval process
The approval process has 2 elements. Once the documents are received by NRS PCC they will allocate a “Generic Reviewer” to conduct the governance checks required and negotiate the contract/budget on behalf of ALL Scottish participating sites. In parallel, local sites are notified that the documents are available and confirmation of capability and capacity (C&C) is carried out at a local level. Once the Generic Reviewer has concluded their review a Scotland wide agreed contract and budget is released. Local sites should accept this without the need for re-negotiation unless there is locally specific costs which need to be added. The local review concludes once the contract is signed, C&C is confirmed and a R&D approval letter is issued.
Amendments
Please do not notify the R&D office directly regarding amendments. NRS PCC inform Scottish sites of amendments as well as the Category and implementation date. Further information can be found at https://www.myresearchproject.org.uk/help/hlpamendmentsresearch.aspx#Sharing-amendments-with-participating-NHS/HSC-organisations
Please note that the commercial team will NOT routinely issue R&D approval letters for amendments.
Local Contact details for Commercial R&D team:
WHEN CONTACTING US ABOUT STUDIES ALREADY SUBMITTED IN IRAS PLEASE QUOTE THE IRAS NUMBER. ACRONYMS AND OTHER REFERENCE NUMBERS MEAN NOTHING TO US. THEREFORE TO ALLOW US TO IDENTIFY THE STUDY QUICKLY THE IRAS NUMBER IS REQUIRED.
For feasibility enquiries: gram.randdfeasibility@nhs.scot
i.e. Pre-approval enquiries such as completion of confidentiality agreements, feasibility questionnaires, site selection visits.
A profile has been created in Shared Investigator Platform for our site facilities http://www.transceleratebiopharmainc.com/initiatives/shared-investigator-platform/
For Generic review enquiries: gram.genericreviews@nhs.scot
i.e. pre-approval negotiating contract/budget and conducting Governance checks if we have been allocated this task by NRS PCC
For Finance/invoicing enquiries: gram.randdfinance@nhs.scot
i.e. post-approval invoicing/queries for all fees associated with the study
For General enquiries: gram.randd_commercial@nhs.scot