As per the Confidentiality Guidelines for Scientific Advice , all documents submitted by the applicant and produced by CADTH as part of the Scientific Advice Program are kept confidential between the applicant and CADTH (including authorized recipients and patient representatives, as applicable).
In order to preserve the confidentiality of the applicantâ€™s information at this early stage of development, CADTH does not disclose any documents submitted by the applicant or any information about the application, including the name of the drug or the name of the applicant, to potential experts or potential patient representatives until a Non-Disclosure Agreement is signed.
By applying to the CADTH Scientific Advice Program, applicants are deemed to give permission to CADTH to disclose information about their application, including applicant name, drug name, and documents submitted and produced as part of the Scientific Advice Program, to experts who have signed a Non-Disclosure Agreement.
Read more about expert involvement in the CADTH Scientific Advice Program.
Patient input is part of the CADTH Scientific Advice Program for all applications. However, documents submitted by the applicant or produced by CADTH as part of the Scientific Advice Program are shared with patient representatives only if permission is granted by the applicant and, in that case, only after a Non-Disclosure Agreement has been signed by the patient representative. Applicants indicate permission to share information in the online application form for Scientific Advice.
Note that submission of the Patient Drug Information Form, an optional form completed by applicants as background information to patient representatives, constitutes the applicantâ€™s agreement for CADTH to share the submitted form with patient representatives involved in the application.
Read more about patient involvement in the CADTH Scientific Advice Program.
By requesting parallel Scientific Advice, applicants are deemed to give permission to CADTH to disclose and exchange information related to the project with the participating organizations. This includes but is not limited to the clarification questions and draft and final versions of the advice developed by each organization. Project staff from each organization may meet at multiple time points to discuss the Briefing Book and responses to the questions posed in the Briefing Book. Any information you provide to each party, in writing or otherwise, is subject to this exchange. Authorized recipients from participating organizations are required to comply with the applicable legislation, policies and confidentiality guidelines to which it is subject, including any freedom of information and access to information legislation.
Read more about confidentiality and information sharing in the CADTH Scientific Advice Program.
Within CADTH, Scientific Advice files are kept in a secure location, with access restricted to CADTH staff involved in the Scientific Advice Program. CADTH staff involved in the Scientific Advice Program are permitted to share information across the organization, as deemed appropriate by CADTH.
All experts, patient representatives, and CADTH staff, privy to Scientific Advice information must comply with the Confidentiality Guidelines for Scientific Advice and the Conflict of Interest Policy for CADTH Employees or Conflict of Interest Guidelines for CADTH Contractors.
Read more about conflicts of interest related to the Scientific Advice Program.