CSP021: CRN Research Delivery Confidentiality Disclosure Agreements (CDAs) Standard Operating Procedure

This Standard Operating Procedure (SOP) outlines step by step the refreshed procedure for the NIHR CRN CC Confidentiality Disclosure Agreements (CDAs) enabling the administration and coordination of the activities of the NIHR Clinical Research Network including provisions of CRN Study Support Service  to researchers and life science companies.

NIHR CRN CC provides the entry point for commercial companies to access the CRN Study Support Services for all new studies.  In the course of providing this service, the NIHR CRN CC handles information provided by commercial companies.  In order to maintain  confidentiality of information defined as such, an agreement is entered into between the sharing and receiving parties. This is the NIHR CRN CC ‘Confidentiality Disclosure Agreement’ or CDA. The CDA enables the company to provide confidential information to the CRN Coordinating Centre as necessary to provide the CRN Support Service from across the entire health and care partners.

Evolving business processes, digital information management (including GDPR) and organisational structure supported a refresh of the approach ensuring  that: 

• Commercial companies have a clear outline of what the data they provide will be used for

• Individuals and organisations understand their obligations with respect to protecting confidential information

Commercial companies request access to the NIHR CRN Study Support Service through the central portfolio management system (CPMS).  Information provided through this  system and  the CRNCC share information, as per our defined business processes,  with the relevant  CRN employed staff based in the Local Clinical Research Networks (LCRNs) in order to provide CRN study support services.  As this structure spans large number of separate legal entities, and works on a cascade approach, we have two agreements in place:

• CDA1 details the terms under which confidential information is shared between the commercial company (acting as study Sponsor or CRO) and the CRNCC. It details the expectations to maintain the confidentiality of the information by explaining what can and cannot be done with the information classified as confidential within the Central Portfolio Management System (CPMS) submission. Only one agreement is required per Sponsor, or their representative, as it covers confidential information relating to ‘current and future clinical studies’ and has a rolling application (i,e, timelines are reset with each new submission). Once in place, CDA1 allows confidential information to be supplied and openly discussed between the Sponsor, or their representative, and NIHR CRNCC staff.  

• CDA2 cascades the terms in CDA1 from CRNCC to any third parties out with the network structure that provides the CRN Study Support Service and thus with which the information will be shared by the CRN CC. This ensures that confidential information (such as study protocols) are only shared when necessary and with the appropriate personnel to maintain its confidential nature. 

Any information provided in the confidential section of the Industry submission form, provided as individual documents marked as confidential  or live study recruitment data provided by the commercial company for inclusion in the Central Portfolio Management System study record is subject to the terms in the CDAs. This information can only be shared with third parties with whom the CRN CC have a complementary CDA2 in place and this process is detailed in the early feedback SOP.

Following site selection, the commercial company will establish Confidential Agreements with each participating site to enable direct exchange of confidential information between the Sponsor/ CRO and the research site. The CRNCC CDA does not cover the provision of information from the commercial company directly to a participating site. 

The NHS have a model Confidential Disclosure Agreement (CDA) which can be accessed via IRAS help 

The NIHR CRN Coordinating Centre (CRNCC) 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 LCRNs each hosted by a single organisation who work with their partner organisations to provide national coverage. More about the structure of the network can be found on our website and in Appendix 1. The following statement captures the intent of the CRN coordination centre  within the disclosure agreement.

“We, the CRNCC hereby undertake to The Company, in consideration of their disclosing Confidential Information as set out in the following terms, in connection with our administration and coordination of the activities of the NIHR Clinical Research Network, being a partnership established by the Department of Health and Social Care to improve the clinical research environment, to receive such Confidential Information on the terms as set forth in this Agreement”.

Activities of the NIHR Clinical Research Network includes the provision of CRN Study Support Service which helps researchers and the life sciences industry plan, set up and deliver high quality research to time and target in both the NHS and the wider health and social care environment. The receipt of confidential information facilitates the following elements of this study support service;

• Early Contact and Engagement:  Promote the CRN support available in general and bespoke to each study

• Early Feedback¹: Commercial studies can access our clinical experts for bespoke study advice across the UK.

• Site Identification¹: Help to identify the most appropriate sites to undertake research across the UK

• Optimising Delivery¹: Building on any early contact discussions, our assessment informs the support studies may need.

• Effective Study Set-up: Our study wide action plan supports rapid set up. 

• Performance Monitoring: our data enables a proactive approach for identifying and supporting struggling studies.

• Eligibility: confirmation of access to NIHR CRN services

¹associated with the feasibility services within the NIHR CRN

2.2.1.  CDAs that were in place prior to the move to DocuSign are stored on the CRNCC Google Drive, however, once the digital process has been fully established then CDAs will be deleted and only stored within DocuSign. Once the new digital process has been fully rolled out this information will be superseded and only names listed within DocuSign will be valid.  

2.2.1. Before initiating a new CDA, DocuSign should be checked to ensure that one is not already signed or pending with the commercial company. The search function in the ‘Manage’ tab of DocuSign can be used to search for the company name in the different ‘quick views’ ( ‘completed’, ‘action required’, ‘waiting for others’, ‘expiring soon’, ‘authentication failed’). 

2.3.1. The following information is needed to generate a CDA1.  The company will be asked to share the information;

• The full registered name and address (including country of operation) of the commercial company

• The commercial company suffix (Ltd, AG, GmbH, Inc) must be included in the commercial company name as this can affect who is covered by the CDA1 within the commercial company

• The registered company number for the company signing. The company should be able to provide this information (Appendix 2), and this will be included in the CDA1 where possible. 

• The name of any subsidiary or affiliate companies the company signing would like to be covered under the agreement

2.3.2 Ideally, the commercial company should have the CDA1 signed by the highest entity possible (i.e the commercial company headquarters) or use the commercial company name and endeavour to include the names of any affiliates. This will reduce the number of agreements needed to cover each country specific branch or division of the overall company (although this may not always be possible).  

2.3.3 The necessary information should be collated and provided to the CRN CC via the Study Support Service Helpdesk (supportmystudy@nihr.ac.uk). The CDA1 can then be sent out via DocuSign. 

 10. Once the CDA has been signed by the company, a copy will be sent to both parties’ email addresses automatically via the DocuSign system. The completed contract will also be stored within DocuSign. 

 11. If the company recipient is unable to sign a CDA1 for any reason, they will have the option to ‘decline’ with a reason. They will also have the option to  either assign the document to someone else via the DocuSign system or to download the contract, get it signed by the appropriate person, and upload it through DocuSign.

 12. Members of the Study Support Service Helpdesk team will be able to monitor the status of any pending requests for CDA1s to be signed by logging into DocuSign.

The commercial company may request additions or changes to the CDA1, however, the CRN cannot accept changes (see section 6) (this new process has already received input from a number of commercial companies).  If you are in any doubt, forward the query and any supporting documentation to the Head of Research Operations or Head of Feasibility and Start-up who will respond on behalf of the NIHR CRN.

Access and distribution of confidential information is in line with the disclosure and CDA terms, therefore CRNCC must assure the CDA status of any individual prior to passing on any confidential information.  

All staff employed to undertake CRN activities at the CRNCC, Local CRN host or partner organisations are subject to the terms outlined in CDA1 as a result of the CRN contractual agreements. CDA2 does not allow confidential information to be shared directly between two or more different institutions (for example between two LCRN host organisations), even when the institutions involved all have CRNCC CDAs in place. This agreement only covers information shared from the CRNCC with the organisation or where information provided by the CC is shared within the same institution.

Therefore, CDA2 agreement is only required by the CRNCC and advisors or specialty group members who provide any element of the CRN study support service  outside of the CRN structure.

The process for use of CDA 2 in context of feasibility is described in the Early Feedback SOP (SOP in preparation/under review).

Electronic signatures can be accepted as the NIHR CRN does not need to hold wet ink copies. 

The following signatories are authorised for each CDA:

• CDA1 is signed by the relevant Sponsor, or company representative and the NIHR CRNCC National Chief Operating Officer.

• CDA2 is signed by the relevant Institution/Personal representative and the NIHR CRNCC National Chief Operating Officer

Source documents stored on the Google drive with access to be requested via the Feasibility & Study Start Up team:

• Video CDA 1 June 2020

• Video CDA 2 June 2020

• Infographic CDA 1

• Infographic CDA 2

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.

Laura Bousfield (Head of Feasibility & Start Up) or Jo Knee (Head of Research Operations), National NIHR Clinical Research Network.

CC: Coordinating Centre

CDA: Confidentiality Disclosure Agreements

CI: Chief Investigator

CRN: Clinical Research Network

CRNCC: Clinical Research Network Coordinating Centre

CRO: Contract Research Organisation

DHSC: Department of Health and Social Care

EF: Early Feedback

HRA: Health Research authority

IT: Industry Team 

LCRN : Local Clinical Research Network

NIHR : National Institute for Health and Care Research

PAF: Portfolio Application Form

PET: Portfolio Eligibility Team

PI: Principal Investigator

R&D: Research & Development

RDD: Research Delivery Directorate

SMT: Senior Management Team

SOP: Standard Operating Procedure

East Midlands : University Hospitals of Leicester NHS Trust

East of England: Norfolk and Norwich University Hospitals NHS Foundation Trust

Greater Manchester : Manchester University NHS Foundation Trust

Kent, Surrey and Sussex : Royal Surrey NHS Foundation Trust

North East and North Cumbria : The Newcastle upon Tyne Hospitals NHS Foundation Trust

North Thames : Barts Health NHS Trust

North West Coast : Liverpool University Hospitals NHS Foundation Trust

North West London : Imperial College Healthcare NHS Trust

South London : Guy's and St Thomas' NHS Foundation Trust

South West Peninsula : Royal Devon and Exeter NHS Foundation Trust

Thames Valley and South Midlands : Oxford University Hospitals NHS Foundation Trust

Wessex : University Hospital Southampton NHS Foundation Trust

West Midlands : The Royal Wolverhampton NHS Trust

West of England: University Hospitals Bristol NHS Foundation Trust

Yorkshire and Humber : Sheffield Teaching Hospital NHS Foundation Trust

The NIHR CRN will request the registered company number to be included in the CDA1 ‘company’ information where possible. This unique identifier supports the NIHR CRN data systems for tracking CDA1 status.

UK based companies

The company registration number for UK based limited companies can be found via the online register ‘Companies House’. 

US based companies

In the US the individual state in which the company is registered is responsible for maintaining the company registry. A list of the links to the database of each state can be found online at Registries in the United States of America 

The Securities and Exchange Commission (SEC) register is only for publicly traded companies but can be accessed online at U.S. Securities and Exchange Commission

EU based companies

The company registration number for EU based limited companies can be found via two registry sources:

• The European Business Registry at https://ebra.be/#

  • The members section provides the latest information on the countries covered by the register

• The Kompany Registry providing company profiles and official register reports

  • Italian companies in this registry require the creation of a free account before the Italian database can be searched

Version number: 1.0 

Effective from date: February 2023