Factors such as site capacity, capability, trial complexity and sponsor acceptance all determine whether a teletrial is feasible. This page outlines the key differences in the feasibility process for a teletrial compared to a standard trial.
For a teletrial, both the Primary Site and the Sattelite Site will need to sign a CDA with the trial sponsor prior to reviewing the protocol.
The Principal Investigator (PI) can request the sponsor to send the CDA to the Satellite Sites.
There are a number of CDAs. For teletrials, a mutual CDA is recommended. If a sponsor does not have a mutual CDA template, a local mutual CDA can be used.
Confidentiality disclosure agreement (CDA) or Confidentiality Agreement (CA)
These are the broad terms used in conversations or emails. You should read the agreements carefully to understand that they may have different meanings and implications.
Non-disclosure agreement (NDA)
Non-disclosure agreement (NDA) is another term for a CDA, used mostly by US-based sponsors.
Study-specific CDAs
Study-specific CDAs incorporate the protocol number/title and allow for the release of information for that protocol only. If you and the sponsor want to enter into a business relationship where you communicate information about future trials that may be of mutual interest, you would need to sign a Master CDA.
Master CDAs or Master Institutional CDAs
Master CDAs or Master Institutional CDAs are made between sponsor and local institution. They allow the flow of information between both parties regarding all future clinical trials without the need for multiple study-specific agreements and are considered a superior type of agreement.
Compound CDAs
Compound CDAs are preferred by some sponsors who don't wish to enter into an open-ended master agreement. This CDA allows for the discussion of more than one clinical trial using the experimental pharmaceutical compounds named in the agreement, however, it is limited in the presentation of other clinical trials using different compounds.
One-way CDAs
One-way CDAs are the most common agreement supplied in a combination of the above (study, master or compound specific). One-way CDAs only protect information provided by the sponsor and do not mention how information supplied by the local institution will be managed and protected. The correct use of this CDA would release the sponsor information to an institution but not allow the local institution to share any information with the sponsor (e.g. complete a feasibility questionnaire). These types of CDAs can be identified within the first few paragraphs. If there is no mention of the sponsor receiving information from the institution and maintaining confidentiality after the statement about a site doing so, the CDA will be one-way.
Mutual CDAs
Mutual CDAs are the correct type of agreement to put in place when sharing any local information with the sponsor. Confidential site information can be defined as information not publicly available on the internet e.g. detailed information needed to complete a feasibility questionnaire. Not all sponsors take mutual agreement into consideration and will commonly send a one-way CDA first. It is acceptable to request a mutual template; if a sponsor does not have a mutual template available, a local institutional mutual template can be used. Most mutual templates will contain the word ‘mutual’ in the title, or in the first few paragraphs. If the site is mentioned as releasing information to the sponsor, then this can be identified as a mutual template.