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Has your practice/organisation considered the TIME commitment for commercial research?
Delivering studies to target are key factors for commercial research. Sponsors will expect prompt responses and actions. Don't forget that they also have timelines to which they are working. Examples of activities which will need dedicated time are:
Study set-up
Completion of Expressions of Interest & Company Feasibility Questionnaires
Site Initiation visit
Attendance at Investigator meeting(s)
Identification of participants
Training, including use of sponsor- specific training and trial databases
Development of any local processes/ standard operating procedures (SOPs)
Communications with study sponsor
Allocating a single point of contact with the sponsor
On going meetings
Monitoring visits-remote/on site
Raising invoices to the sponsor and dealing with any invoicing queries
Research delivery, including follow ups
PI Oversight
Scheduling patient visits, dealing with patient enquiries between visits, following up any trial-related activities they do at home (e.g., study drug compliance, completion of diaries and questionnaires)
Reviewing reports e.g., lab results
Signing off case report forms (CRFs)
Safety reporting
Data management (e.g., data entry, data queries, database lock requirements)
Other study specific requirements (e.g., out of hours cover)
Maintaining the Investigator site file (paper/ electronic)
Managing payments to participants (e.g., travel reimbursement)
Close-out activities
Archiving of site files and source data
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Has your practice/organisation established a RESEARCH TEAM?
Who is in your research team? This may vary across sites and for each study. The Principal Investigator (PI) is the individual responsible for the conduct of the research at a site & delegation of activities to rest of the research team. The research team may include:
Principal Investigator (PI)
Co-Investigator(s) or sub-Investigators
Research Nurse(s)
Clinical Research Practitioner (CRP) / Allied health professionals (AHPs)
Pharmacist
Research/Practice/Business Manager
Study Coordinator
Clinical Trials Assistant
Administrative Support
Finance Support
Support can be provided by our peripatetic RRDN primary care nurse team to support the delivery of commercial research at the site (with experience working in blinded & unblinded roles). This will depend on the region & further information can be provided as required.
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Does your team have the relevant EXPERIENCE/TRAINING required for commercial research?
Sponsors will ask for evidence of experience & training of the research team. This includes PI experience, i.e. number of years’ experience / previous involvement in studies (commercial/non-commercial, number & type).
A template Investigator CV can be found on the HRA website. This can be used by all members of the research team as required.
Consider the required training within your organisation.
Free training is available to staff via NIHR Learn for those working on NIHR Portfolio studies (commercial and non-commercial)
Please refer to Training page.
There will also be study specific training to be completed. This will be requested by the sponsor.
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Have you considered the FACILITIES and PROCESSES your practice/organisation may need in place for commercial research?
The facilities required will be study specific, general considerations are below. Consider what you may have in place already.
Clinic Rooms- more than one clinic room may be required depending on the delivery model for the study & how many members of the research team will be on site at the same time
Secure Storage with limited access - storage for study specific materials and equipment. Sponsors may provide a large amount of equipment/supplies and this could require a significant amount of storage space e.g., large boxes of lab kits, ancillary supplies, ECG machine, printer, laptop, tablets/smart phones
Archiving on site/off site - consider if long term storage will be required e.g. 15- 25 years. Locations require prevention against, flood, fire, and theft.
Remote Monitoring- can this be accommodated? What arrangements need to be put in place?
On Site Monitoring- can this be accommodated? Is Wi-Fi access available? How will the monitor be given access to the source data e.g. electronic health records?
Good Wi-Fi is also required if transmitting ECGs, setting up electronic diaries etc.
Pharmacy/Dispensary
Lab processing - for more complex commercial studies, there could be the requirement for the processing of samples at the trial site. The RRDN can provide guidance, as required.
Are relevant Local Standard Operating Procedures (SOPs) in place?
Sites need to be Audit/ Inspection ready
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Have you considered any specific EQUIPMENT your practice/organisation may need for commercial research?
Equipment required will be study specific, general considerations are below. Occasionally specific equipment may be provided by the sponsor. The practice may wish to ask the sponsor to loan equipment or consider hiring specific equipment required for this study.
Vaccine Fridge (s) - does your organisation have a dedicated vaccine fridge to store the Investigational Medicinal Products (IMP)? How is the temperature of the vaccine fridge(s) monitored? How will temperature excursions be identified?
Locked Drug Cupboard - how is the temperature monitored? How will temperature excursions be identified?
Minus 20 Freezer - how is this temperature monitored? How will temperature excursions be identified? Some studies may require a -80 freezer
Temperature monitoring is also required for study drug stored at ambient temperature - sponsor may be able to provide a electronic temperature monitor for this purpose
Centrifuge
Resus Trolley/Equipment
Defibrillator
Calibration Certificates - do you have these in place and are they readily available for the sponsor representative to review?
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Have you considered Investigational Medicinal Product (IMP) management requirements?
Who will undertake the IMP management requirements? How will this be done? This should also be a consideration when completing company feasibility surveys.
IMP Management, including:
Preparation of IMP handling manual
Delivery and receipt
Storage and temperature monitoring
Managing temperature excursions
Are there any out of hours arrangements that could be implemented e.g., if temperature excursion out of hours? Not mandatory however, but useful
Managing clinical trial drug recall
Managing pharmacy clinical trial documents
Drug accountability
Preparation and administration of IMP - Blinding and Unblinding Requirements
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Have you considered the STUDY COSTINGS AND CONTRACTS?
Who will be responsible for reviewing the study costs & contract / agreements e.g. service-level agreements?
Who will be the signatory for your organisation? Please note, the PI cannot sign the contract; someone else in your organisation will need to sign the contract.
Commercial Model Clinical Trial Agreements and guidance notes can be found on the IRAS website.
Has your practice signed up to the National Contract Value Review (NCVR) - this will take the burden of costing and contract negotiation away from general practices. Commercial sponsors of research can view the list of GP practices that have signed up to NCVR to support site-selection decisions for future trials
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Have you considered individual responsibilities, such as SITE FILE MANAGEMENT, and DATA MANAGEMENT?
Consider who will undertake data entry within the required timelines.
Who will deal with data entry, data queries and timelines, including for the database lock (interim and final)?
Who will be responsible for managing the site file (including site file maintenance e.g. amendments, version control, file notes)?
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