Hosted Research Pathway
The PHT Hosted Research Pathway is for research with an external Sponsor in place and to be hosted by the Trust
Hosted EOI Confirmed - Milestone 1
The first step is to identify your study. Our team can help you to find studies currently open to recruitment and advise keeping a constant eye on the NIHR Portfolio database for new studies in set-up. When a study has been found that you are interested in a feasibility assessment should be carried out to ensure, in principal, that the study can be supported at PHT.
Contact the R&D office to make an expression of interest (EOI). If the study is on the Portfolio the R&D office will liaise with the Comprehensive Research Network (CRN) to communicate the EOI. If the EOI is successful we will be notified and PHT will be added as a site to the R&D form.
Capability Confirmed - Milestone 2
The next stage involves gathering together all the study documents such as:
- Protocol
- R&D form
- Patient information sheet
- Consent form
- GP letter
The site specific information form (SSI) will also be requested at this time. The R&D office lead for the department (research facilitator) will then contact the team to arrange a convenient time to meet and discuss the logistics of the study and confirm details in the SSI form. In this meeting any required support departments will be identified to R&D for further consultation, for example Pathology, Pharmacy, Radiology, Radiotherapy and Clinical Engineering. R&D will communicate with all parties that will be asked to support the study to ensure they are in agreement.
When the local study team and all the corresponding support departments have confirmed they are capable of conducting the study according to the protocol then the set-up of the study has reached milestone 2.
Global Checks
All studies will undergo local and global governance checks. The global checks will be completed by the lead site and sometimes this is identified to be PHT. The R&D office will be assigned the task to complete the global governance checks by the CRN. Global governance checks look at the study as a whole and reviews such details as regulatory approvals, data protection, mental capacity and human tissue act compliance.
Global governance checks must be completed before local governance checks can be confirmed. These checks will be uploaded to CSP/RDMIS for all sites, participating in the study, to view.
Valid Pack Submitted - Milestone 3
The Research Facilitator will circulate the finalised SSI form to the team for review and approval. Once approved, the Facilitator will compose “the valid pack” consisting of:
- SSI form
- IRAS checklist
- Signed & dated CVs for all members of the study team
- Locally headed patient related documents
These documents will all be ‘submitted’ on IRAS, the Integrated Research Application System. This action will ‘lock’ the SSI form ready for final authorisation.
PHT Permission issued - Milestone 4
Once the valid pack has been submitted, the R&D office aims to approve the study within 15 days. This guidance has been set by the NIHR. During this period all those identified on the SSI form to give authorisation will be contacted for their sign off. It is at this time that the local governance checks are done, according to the NIHR Guidelines, by the Research Facilitator. This is to assure that the Trust meets all regulatory requirements for the particular study in question. Different “checks” are done for different types of studies.
When all approvals have been received back and the governance checks are complete, R&D permission can be granted.
Site Initiation / Opened - Milestone 5
The majority of studies will have a site initiation visit (SIV) conducted by the Sponsor’s representative or study coordinator. The R&D office will liaise with the local study team and the central team to arrange a mutually convenient date to schedule the SIV. SIV’s can take the form of a face-to-face meeting or a teleconference.
When we grant R&D permission we try to align this with the site initiation visit to prevent any delays in recruitment, however in some circumstances R&D permission is required before the SIV can be arranged. For example, some CTIMP studies require R&D permission before they can ship the IMP, once the IMP has been shipped to our Pharmacy local Pharmacy processes need to be completed before an SIV can take place.
Following the SIV the Sponsor’s representative or study coordinator will confirm PHT is now open to recruitment.
First Patient First Visit
To meet the NIHR’s aim of increasing the numbers of patients who have the opportunity to participate in research and enhance the nation’s attractiveness as a host for research, a benchmark timeline has been published. This benchmark timeline features a target to recruit the first patient within 70 days from valid pack submission. From 2013 this target becomes even more important as funding received from the NIHR is affected by our performance in meeting our targets.
To discuss your Research idea, please e-mail the Research Office inbox () or call the R&D office (ext. 6236). Please contact us early on so that we can guide you through the process.
Hosted Pathway: 14 November 2014; v3