- How do I get site approval?
- What is a study sponsor?
- Other site-specific issues that need to be covered
How do I get site approval?
I want Barts Health or Queen Mary to be a recruiting site for externally sponsored study
Barts Health and Queen Mary are keen to take part in good quality externally sponsored research projects. Researchers should contact the Research Governance Team (RGT) at firstname.lastname@example.org as soon as possible when contacted to take part in externally sponsored research.
Where Barts Health is invited to participate as a site, it has to either confirm capacity and capability to take part in research or decline the study, if deemed not feasible.
The RGT reviews the study and confirms the capacity and capability of Barts Health to participate in the research.
In research studies, the study funder and study sponsor are two distinct roles and can be one organisation or two separate organisations:
- The study funder is an organisation who agrees to fund all or part of the research.
- The study sponsor is an organisation that takes overall responsibility for the research project, they may or may not fund the research.
For most investigator-led studies, where CI is the author of a study protocol, the substantive employer of CI will act as the study sponsor. Where a company or organisation has developed the protocol, the company or organisation will act as the study sponsor.
The majority of academic studies fall under the former category, while the majority of commercial studies will fall under the latter category.
More details about the study sponsor, including their role or remit, can be found on the HRA website.
If you are unsure about who is sponsoring the study, please email the research governance team.
The study sponsor is responsible for inviting the research site by contacting site’s R&D office, Site or local study team and respective NIHR Clinical Research Network ( if applicable) by a single email with the “Local Information Pack” (LIP) attached. The LIP usually (but not necessarily) consists of:
- Current Study Protocol
- IRAS form
- HRA approval letter/ HRA initial Assessment Letter
- Other applicable Regulatory approvals (NHS REC, MHRA, Section 251 approval etc.)
- All participant-facing documents to be used at the site
- Site Agreement / Contract preferably unmodified mNCA or mCTA (if applicable)
- NIHR commercial costing template ( if applicable)
- HRA Statement of Activity
- HRA Schedule of Events
- Investigators Brochure / SmPC ( if applicable)
- Any key documents (depending on study type, activities at site and site requirements)
- Any other study documents that the sponsor wishes to provide to the site to support the setup and delivery of the study
Please contact the Governance team immediately on receipt of any/all of the documents listed above to enable them to start the review process. The Joint Research Management Office has two separate processes for confirming capacity & capability to host NHS research as listed below:
NIHR Portfolio adopted studies
Barts Health has an arrangement with North Thames Clinical Research Network (NT CRN) to review (including costing & contract, Medical Exposure and Pharmacy reviews) all NIHR portfolio adopted studies and all non- NIHR portfolio commercially sponsored studies on behalf of Barts Health and confirm capacity & capability. If you are contacted to take part in an NIHR portfolio adopted study, please contact Research Governance Team: email@example.com copying North Thames CRN Study Support Service firstname.lastname@example.org.
North Thames CRN works closely with JRMO and the site to review feasibility for the study. They will:
- Review costing and contracts / Schedule of Events and Statement of Activity
- Review and seek approval for any support department like Imaging, pharmacy etc.
- Seek Authorisation for Clinical Director and the JRMO
- Review local capacity & capability with the support of site & the JRMO
- Formally confirm capacity & capability on behalf of Barts Health
It is important that BH researchers inform both organisations immediately as for certain study types the NIHR expects Barts Health to recruit the first patient within 70 days from the date that the site was selected. BH is expected to provide this data to NIHR CCF every quarter in Project Initiation and Delivery (PID) Report. Failure to provide data or meet 70 days metrics may incur a penalty for Barts Health.
Non-NIHR portfolio adopted studies:
If you are contacted to take part in a non-NIHR portfolio non-commercially sponsored research study as a site, please contact the Research Governance Team at email@example.com immediately.
Additionally, ask the study sponsor to copy firstname.lastname@example.org in all the study correspondence. Research Governance Team will liaise with the study sponsor regarding documentation, review the study and confirm the capacity and capability of Barts Health to host the study. The Governance team will use the checklist of documents to review the study and confirm the capacity and capability of Barts Health to host the research.
Confirmation of capacity & capability cannot be given until all other relevant regulatory or other approvals (e.g. HRA, REC, MHRA, and NIGB) are in place. If your study involves a contract or agreement, this will also need to be fully executed before confirmation of capacity and capability.
For studies carried out on University premises, a non-NHS SSI form may be required. All Site Specific Assessments (SSAs) for non-NHS sites are now undertaken by the main NHS REC carrying out the ethical review of the research ethics application.
For Non-NHS SSI forms the Queen Mary Institute manager or Director will sign/authorise the form on IRAS.
- Data Protection Act 1998 - As a researcher at BH, you must abide by the Data Protection Act and the Trust data protection policy. Further information is available here, or with the Governance team.
- Peer review - All research should be appropriately reviewed, not only for its scientific rigour but also for strategic fit and the use of available resources. Each Barts Health clinical team or Queen Mary institute has appropriate systems to review prospective research. The PI must ensure their proposed studies are reviewed as per SOP 14
- Training - Barts Health expects all researchers including the PI to be fully qualified and trained to deliver the research. Training courses are available with the GCP team. Where the sponsor is external it is the sponsor’s responsibility to assess the suitability of the JRMO courses.
- Pharmacy Approvals - Any study involving a medicinal product or drug (CTIMPS and NON-CTIMPS) requires review and approval from the Clinical Trial Pharmacy. All queries about the Clinical Trial Pharmacy services should be emailed to CTpharmacy@bartshealth.nhs.uk and for any pharmacy approval or pre-approval related inquiry for NIHR portfolio adopted studies please contact North Thames pharmacy team at email@example.com
- Imaging Approvals - Any trials involving on X-ray, DEXA, MRI, CT, Ultrasound and PET will need review and approval from the Imaging Research Team at BH. Our clinical imaging centres are spread across the trust and provide: Scanning; trial specific reporting; peer review; training and education; and protocol development support. If you require any further assistance on how the imaging team will be able to support your study, please contact Gayathri Delanerolle: Gayathri.firstname.lastname@example.org. For NIHR portfolio adopted studies imaging approval / pre-approval related enquiry please contact North Thames imaging team: email@example.com
- Costing and Contract Review: For NIHR portfolio and commercially sponsored projects Costing and contract will be performed by the North Thames CRN. Please contact North Thames CRN Study Support Team on firstname.lastname@example.org.
Contracts and costs are reviewed by JRMO for all non-NIHR portfolio Non-commercially sponsored studies hosted by BH or QMUL. All new costing queries should be directed by using the newly-launched online Pre-Costing Questionnaire (PCQ). On submission of the new PCQ, an email will be automatically generated and sent to a new generic email address in the JRMO, used purely for costing requests email@example.com. If you use the paper version of the PCQ, please send it to this email address. Please note that initially this will be only used for non-EU Commission costing requests.
You can find the on-line PCQ at https://webapps2.is.qmul.ac.uk/ecosting. Any queries with the PCQ or if you are a Barts Health employee without a QMUL log in please ring: Jackie Fedden Ext 7201 or email firstname.lastname@example.org.
For all NIHR portfolio adopted studies where Barts Health NHS Trust is participating as a site, North Thames Clinical Research Network conducts costing and contract review as part of the agreed Harmonisation programme. For such studies please email costing template/schedule of events and template contract/ Statement of Activities to North Thames CRN Study Support Service email@example.com.
- Pathology and CSS approvals: If a hosted study requires pathology service has a review process. Please contact Sarah.Mahmood@bartshealth.nhs.uk and Gayathri.firstname.lastname@example.org for more details.
- Commencing the study: You should contact the sponsor when you are ready to begin your study when you have all the approvals and applications, and Barts Health has confirmed capacity and capability to host the study. The sponsor should then email to confirm that they are happy for you to start the study.
BH records and uploads all recruitment details on the Clinical Research Network Local Portfolio Management System (LPMS) for all NIHR portfolio adopted studies. The North Thames CRN uses a database called EDGE. As a BH researcher, you must ensure that patient recruitment data for every NIHR portfolio adopted study is uploaded on EDGE regularly. If you do not have access to EDGE or have any query please email email@example.com
- Accessing health records: You will need to hold a Barts Health NHS Trust Letter of Access or Honorary Research contract. For more information see the Personal Access for Research page.
All requests for Barts Health patients’ health records must be made in writing using a request for health records form. Both research and audit requests should be directed to Katherine Moore, Senior Supervisor in Health Records, katherine.moore@bartshealth,nhs.uk.