1. INTRODUCTION 2. SCOPE 3. PROCESS

Size: px

Start display at page:

Download "1. INTRODUCTION 2. SCOPE 3. PROCESS"

Griffin Robbins
6 years ago
Views:

2 1. INTRODUCTION This SOP has been produced in accordance with the Research Governance Framework for Health and Social Care, 2 nd Ed., 2005, and The Medicines for Human Use (Clinical Trials) Regulations 2004 incorporating Statutory Instruments 2004 No. 1031, 2005 No. 2754, 2005 No. 2759, 2006 No. 1928, 2006 No. 2984, 2008 No. 941 and 2009 No This SOP will outline the procedure for ensuring and maintaining confidentiality of commercially sponsored clinical research studies undertaken at Nottingham University Hospitals NHS Trust (NUH). A clinical trial protocol and associated documentation including know how developed by a commercial company remains the property of the commercial company. A commercial company will often ask the Principal Investigator (PI) to sign a Confidential Disclosure Agreement (CDA) prior to or at the same time as providing a copy of the protocol to the PI. A CDA signed by the PI prevents the PI from disclosing the commercial company s proprietary information to any other individual or organisation except those explicitly identified as authorised individuals. A CDA signed by the PI does not bind NUH as an institution to the terms of the Agreement. To bind NUH to the CDA requires signatory by an authorised representative of the Trust. For research studies authorised signatories should be obtained by contacting the R&D Department. It is the commercial company s decision as to whether they require signature to a CDA before releasing study information. 2. SCOPE A Confidentiality Disclosure Agreement (also known as a Non-Disclosure Agreement (NDA)) is a legally binding document which defines the rights and obligations of each party in relation to the use of information shared between the parties. The document will state that the Investigator (including their staff) will not release (hard copy, verbal, soft copy) any information regarding the study to anyone without the written permission of the commercial company. 3. PROCESS Confidentiality Agreements 1. The commercial company sends the PI an agreement regarding confidentiality by post, or fax. There should be one (1) copy per signatory to the agreement. If required the NUH template (appendix 1) can be used. Research Page 2

3 2. The PI sends the Research Governance Facilitator/Research Manager (RGMF) a copy of the CDA for review. If the PI signs the CDA without Trust review and signature, the PI will incur sole responsibility for fulfilling the obligations of confidentiality. 3. The PI signs the CDA (where appropriate) on behalf of himself and the members of the research team and forwards it to the Trust Research and Development Department for review and Trust signature. A copy will be returned to the PI with signed originals being returned to the commercial company and retained by R&D for the master file. 4. If the study goes no further, the PI files the CDA appropriately in his personal files. 5. For registered projects, upon receipt of the study protocol the RGMF files the study protocol in the master study file, which is accessible only by members of the Research and Development Department staff. 6. The PI is responsible for securely storing their copies of the protocol and associated study documentation. NUH Research and Development Confidentiality 7. The Research and Development Department does not reveal the nature of commercially sponsored research taking part within the Trust to any other individual or organisation. SOP REVIEW PERIOD This procedure will be reviewed by the owner on a biennial basis, unless new local, national and/or international recommendations force an earlier review. Research Page 3

4 Appendix 1 Confidentiality Agreement Template This Agreement is made the DATE Day of MONTH 20YY ( Effective Date ) BETWEEN Insert Individual s Name, who is employed by Nottingham University Hospitals NHS Trust, having principle offices at, E11 Curie Court, Queens Medical Centre Campus, Derby Road, Nottingham NG7 2UH And Insert Company Name/Individual, having a registered office at, Insert Address Hereinafter referred to as Party or Parties WHEREAS (A) The Parties hereto are willing to disclose certain confidential information for the purposes of entering into discussions and/or collaborative efforts relating to INSERT FIELD OF WORK hereinafter referred to as the Purpose and subject to the terms and conditions herein. (B) For the mutual benefit of both Parties and pursuant to this Agreement confidential information includes but shall not be limited to; all technical and non-technical information relating to the Purpose provided by either Party to the other including but not limited to patents, patent applications, trade secrets, copyright and any such other proprietary information consisting of ideas, techniques, sketches, drawings, works of authorship, models, inventions, know-how, processes, apparatus, equipment, algorithms, software programmes, software source documents, and associated formulae relating to the current, future and proposed products and services of each of the parties, and including, without limitation, their respective information concerning research, experimental work, development, design details and specifications, engineering, financial information, procurement requirements, purchasing, manufacturing, customer lists, investors, employees, business and contractual relationships, business forecasts, sales and merchandising, marketing plans and information the disclosing party provides regarding third parties. In consideration of the mutual promises and covenants contained herein the Parties HEREBY AGREE AS FOLLOWS: 1. For the purposes of this Agreement Confidential Information shall be all information disclosed (whether orally, in writing or by any other means) by either Party to the other whether before or after the Effective Date of this Research Page 4

5 Agreement regarding the Purpose as specified at (A) however shall not include any part of such information which: a) is in or comes into the public domain in any way without breach of the Agreement by receiving party; or b) the receiving party can show (i) was in its possession or known to it by being in its use or being recorded in its files prior to receipt from the disclosing party and was not acquired by the receiving party from the disclosing party under an obligation of confidence; or (ii) to have been independently developed by the receiving party; or c) the receiving party obtains or has available from a source other than the disclosing party without breach by the receiving party or such source of any obligation of confidentiality or non-use; or d) is hereafter furnished by the disclosing party to a third party without restriction on disclosure or use; or e) is disclosed by the receiving party with the prior written approval of the disclosing party; or f) Is subject to a disclosure under a statutory, legal or parliamentary obligation placed upon the Party making the disclosure, including any requirements for disclosure under the Freedom of Information Act (FOIA) Each Party agrees to treat the Confidential Information received from the other Party or from a third party on behalf of the other Party as follows: a) In confidence and to use it only for the purposes of establishing a research or business relationship for the specified Purpose and not for any other commercial purpose without further express agreement of the other Party b) Not to copy or write down any part of the Confidential Information except as is reasonably necessary for the purposes aforesaid and in such circumstances the copies or written documentation shall remain at all times the property of the disclosing party; c) to disclose the Confidential Information only to such of their directors, employees or third parties as may need to know the Confidential Information for the purposes aforesaid and only if such directors, employees or third parties are subject to the same obligations of confidentiality as are contained in this Agreement and T.G. and the Company (as the case may be) undertakes at its own expense to enforce such obligations of confidentiality against such directors, employees and third parties. Research Page 5

6 3. Each party undertakes to the other that at the request of the disclosing party the receiving party shall; a) Promptly return to the disclosing party all documents, materials and records of all copies made thereof of the Confidential Information; b) Certify in writing to the disclosing party that all the terms of this Agreement have been complied with; c) Remain bound by clause 2 for a period of 5 years following execution of this Agreement. 4. No rights or obligations other than those expressly recited herein are to be implied from this Agreement. No licence or proprietary right is hereby granted, direct or indirect, under any patent, copyright or other intellectual property right now held or which may be obtained or which is or may be licensable by either Party pursuant to this Agreement. 5. Each Party agrees to keep the existence and nature of this Agreement confidential and not to use the Agreement or the name of the other Party in any publicity, advertisement or other disclosure with regard to this Agreement without the prior written consent of the other party. 6. This Agreement may be executed in any number of counterparts each of which shall be an original but all of which together shall constitute one Agreement. This Agreement shall become effective upon the execution of at least one counterpart by each Party. 7. The interpretation, construction and effect of this Agreement shall be construed in all aspects in accordance with English Law. IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed as of the Effective Date Signed by an authorised signatory For and on behalf of Nottingham University Hospitals NHS Trust Signed: Position: Date: NUH Employee Signed: Position: Date: Disclosing Party Signed: Position: Date: Research Page 6

7 Research Page 7

NON-DISCLOSURE AGREEMENT ( BILATERAL ) Executed as of the day of.

NON-DISCLOSURE AGREEMENT ( BILATERAL ) Executed as of the day of. BETWEEN: UNIVERSITI TEKNOLOGI MALAYSIA, a body corporate incorporated under the Universities And University Colleges Act 1971 and having