NIHR Clinical Research Network: Confidential information arrangements for the Life Sciences Industry feasibility services
This document is issued and updated by the NIHR Clinical Research Network (CRN) Coordinating Centre. A pdf version is available on request from email@example.com
- Version: April 2019 (supersedes version, January 2018)
- Effective date: 1st April 2016
- Function: To support the use of the NIHR CRN Feasibility Services for the Life Sciences Industry
- Audience: All users of the NIHR CRN Feasibility Services for the Life Sciences Industry
- Purpose: Clarification of the NIHR CRN arrangements for maintaining the confidential nature of information supplied by Life Sciences Industry in during the submission process for NIHR CRN Life Sciences Industry feasibility services.
The NIHR Clinical Research Network (CRN) utilises a two-tier Confidential Disclosure Agreement (CDA) system to cascade information related to the CRN Life-Sciences Industry Feasibility and Eligibility Service within the wider Network structure of 15 Local CRN host organisations, which enables delivery of the service across the NHS. This approach requires the use of the NIHR CRN standardised templates to allow information to flow quickly and in confidence to support study design feedback and potential site identification.
Once sites are selected for a study, companies can initiate their own generic, compound or study-specific confidentiality agreements directly with the NHS Organisations in order to share and communicate further confidential information for study set-up.
NIHR CRN Structure
The NIHR CRN Coordinating Centre (CC), providing the CRN headquarters function, is hosted by the University of Leeds in a consortium partnership arrangement with Guys and St Thomas’ NHS Foundation Trust. The wider network consists of 15 Local CRNs hosted by a single organisation who work with their partner organisations to provide national coverage. More information about the structure of the Clinical Research Network is available here.
For NIHR CRN commercial feasibility and eligibility service to be conducted efficiently, NIHR CRN CC staff must be in a position to discuss and provide the relevant confidential information to other NIHR CRN employees, affiliates, and advisors who are not employees of the University of Leeds as appropriate. This includes members of the Specialty Groups and Local CRN staff who are employed by other NHS organisations or Higher Education Institutions, rather than the University of Leeds (the NIHR CRN CC host organisation).
CRN Feasibility and eligibility process
The NIHR CRN CDA templates cover the life-sciences industry feasibility and eligibility process to determine study deliverability in the NHS which consists of a number of offerings:
- Early Feedback: This service supports protocol development and/or the decision to place a study in the UK.
- Site Identification: To identify sites, or to add to those companies have already selected and assess portfolio eligibility.
- Site Intelligence: Designed to complement a company’s own feasibility for pre-selected sites and assess portfolio eligibility. The company will receive Network assessment of site capability, capacity and performance for any sites already identified to confirm the network support available for any pre-selected sites.
- Costing Template Validation: In preparation for site selection to commence assessment, arrangement and confirmation of local capacity and capability.
For the Site Intelligence and Site Identification service offerings, companies are required to certify that a study meets the following eligibility criteria in order to qualify for Network support:
- The study must meet the definition of ‘research’ (see below for definition), and;
- The study must receive NHS Research Ethics Committee approval and NHS permission prior to initiation at individual sites.
- Note that a company may not have received these approvals at the time of making their submission for feasibility assessment – confirmation that a study will apply for both approvals will be sufficient for services to commence.
Research is defined as the attempt to derive generalisable (i.e. of value to others in a similar situation) new knowledge by addressing clearly defined questions with systematic and rigorous methods. Visit the Health Research Authority website for more information on the Research Governance Framework for Health and Social Care (England).
This excludes: audit; needs assessments; quality improvement and other local service evaluations. It also excludes routine banking of biological samples or data except where this activity is integral to a self-contained research project designed to test a clear hypothesis. NHS Research Ethics Committee approval and NHS permission are requirements for research to be supported via the NIHR CRN.
Two-tier CDA system
The NIHR CRN two-tier CDA system allows discussions regarding feasibility and eligibility of the study for delivery in the NHS to take place without being delayed by individual Sponsor CDA discussions with each potential site (the NHS consists of over 250 individual NHS Organisations and more than 10,000 General Practices). This is achieved through the use of generic, standardised CDA templates to manage confidential information sharing across the CRN as show in Figure One.
First tier - CDA1 between the NIHR CRN CC and the Sponsor
CDA 1 provides a one-way confidentiality undertaking between the Sponsor (or representative submitting information on behalf of the Sponsor such as a Contract Research Organisation), as the disclosing party, and the University of Leeds (acting as host to NIHR CRN CC), as recipient. Only one such agreement is required per Sponsor, or their representative, as it covers the supply of confidential information relating to “current and future clinical studies programmes”. Once in place, CDA1 allows confidential information to be supplied and openly discussed between the Sponsor, or their representative, and NIHR CRN CC staff employed by the University of Leeds. A 10 year term of confidentiality is applied from the date each piece of information is shared, thus there is no expiry for the CDA.
Second tier - CDA2 between the NIHR CC and the recipient supporting feasibility
CDA2 cascades the terms of the CDA1 to allow the sharing and discussion of confidential information between the NIHR CRN CC and appropriate CRN employees, affiliates, and advisors involved in delivering and supporting Industry Feasibility Services who are employed by organisations other than the University of Leeds. The NIHR CRN CC will only share confidential information with other network organisations or individuals as necessary to provide the feasibility services with which it holds a CDA2.
How does this system help the Sponsor?
The feasibility services help to provide national insight into delivery within the NHS setting and focus site selection across all NHS organisations prior to investigating time in detailed discussions. It would be time consuming to generate individual Sponsor-to-Site CDAs at this point so the two-tier system allows minimal information to be shared in order to provide initial feedback or an expression of interest.
Sponsor CDAs can then be put in place with each site which the Sponsor would like to consider further which would enable the direct distribution of confidential information and minimise paperwork for the Sponsor.
All information submitted by the Sponsor to the NIHR CRN in relation to a proposed or ongoing study is considered proprietary and sensitive and NIHR CRN assures companies that this information will be handled in the strictest confidence. To further embed this principle into everyday CRN operations, this requirement is written into the Local CRN host and partner organisation contracts as a condition of which each Local CRN receives their funding allocation.
Accessing one or more of the feasibility services requires the completion of an online ‘submission form’ within the through the online system which categorises the information into confidential and non-confidential (but still considered commercially sensitive) information. This information is categorised this way because it is distributed differently, as detailed in table 1.
|Section||Section A – Confidential||Section B – Non-confidential (but commercially sensitive)|
|Format||Service requirements, company contact details and documents such as the protocol||General information regarding study requirements as provided by the applicant to a level of detail at which they are comfortable e.g. blinded study synopsis or inclusion/exclusion criteria.|
|Distribution||Third parties with whom the NIHR CRN have a CDA in place with e.g. Local CRN to undertake costing template validation||May be distributed to the wider research network community as deemed appropriate for the service selected. Marked as commercially sensitive, however considered appropriate for circulation without the need for a formal CDA.|
|Receiving parties||Only shared with the relevant CRN CC staff, Local CRN staff and/or Specialty Group members depending on the service selected.||Shared with the relevant CRN CC staff, Local CRN staff , relevant Specialty Group members and/or the partner organisations/potential site as deemed appropriate for the service selected.|
Any additional confidential information provided to the CRN CC in support of the submission, such as the protocol, will not be distributed outside of the CRN or Specialty Group members as appropriate to the service selected. The information distribution is summarised in Table Two.
|Recipient||Part A (Confidential)||Part B (Nonconfidential)||Additional documents (confidential)||Additional documents (Non confidential)|
|National CRN Coordinating Centre Staff||YES AS REQUIRED||YES AS REQUIRED||YES AS REQUIRED||YES AS REQUIRED|
|Local CRN Staff including those within NHS organisation (Local CRN devolved model)||YES AS REQUIRED||YES AS REQUIRED||YES AS REQUIRED (e.g. protocol for costing template validation)||YES AS REQUIRED|
|Speciality Group Members (at NHS organisations or Higher Education Institutes)||IF REQUIRED||IF REQUIRED||YES AS REQUIRED (e.g. study design for early feedback)||IF REQUIRED|
|NHS organisation staff supporting CRN activities (e.g. R&D manager supporting site identification)||NO||YES AS REQUIRED||NO||IF REQUIRED|
|NHS organisation staff NOT involved in CRN activities||NO||NO||NO||NO|
Electronic signatures can be accepted as the NIHR CRN does not need to hold wet ink copies. If the Sponsor, or company, requires wet ink copies, the NIHR CRN should be notified when setting up the CDA in order to provide this.
The following signatories are authorised for each CDA:
- CDA1 is signed by the relevant Sponsor, or company, representative and the NIHR CRN CC Director for Research Delivery.
- CDA2 is signed by the relevant Institution/Personal representative and the NIHR CRN CC Director for Research Delivery.
The NIHR CRN does not accept any requested amendments to the CDAs for the following reasons:
- Any changes to the CDA1 would need to be reflected in CDA2 of which there are hundreds of already established agreements.
- It is not practical to cascade a range of different terms for each Sponsor or company into the CDA2s to accommodate these across the CRN CDA system.
- The CRN information management systems and processes are not designed to accommodate varying terms within the CDA for different companies and thus the NIHR CRN cannot agree to changes that cannot be reflected in practice.
Registered Company Number
The NIHR CRN will request the registered company number to be included in the CDA ‘company’ information where possible. This unique identifier supports the NIHR CRN data systems for tracking CDA status.
- CDA - Confidential Disclosure Agreement
- CRN - Clinical Research Network
- CRN CC - Clinical Research Network Coordinating Centre
- NHS - National Healthcare Service
- UoL - University of Leeds
Refreshed Confidentiality Disclosure Agreement (CDA) for commercial sponsors and CROs
- Supporting infographic: Introducing changes to the CDA process for commercial companies
Process for commercial Early Feedback reviewers and arrangements for Confidentiality Disclosure Agreement (CDA) requirements
- Supporting infographic: Changes to the Confidentiality Disclosure Agreement and Early Feedback Review process