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 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 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 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 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.
Once the CDA is complete, the sponsor will send through a Feasibility Questionnaire and draft protocol to all sites. The site is not committed to the trial at this point.
This is the time to ask the question: Can this trial be run as a teletrial?
The chance to run a trial as a teletrial should be raised by the PI in response to the initial enquiry from the sponsor, or in the PI's approach to the sponsor.
Both Primary and Satellite Sites complete the Feasibility Questionnaire to:
A helpful checklist in Excel format may be found on the CT:IQ resources page: CT:IQ Early Phase Trials Best Practice Checklist
If after the Feasibility Questionnaire a site seems feasible, that site can request a final protocol from the sponsor. The site is still not committed to the trial at this point.
A more detailed internal feasibility process should be undertaken with the final protocol. Under the teletrial model, a Satellite Site is not required to have the capability to conduct all aspects of a trial.
Commitment to a clinical trial should be contingent on review of the final protocol.
The PI, Feasibility Coordinator and Study Coordinator should complete an internal feasibility assessment prior to the site selection visit to prepare to address queries and potential issues at that meeting.
The schedule of events in the protocol can be a useful tool when conducting this assessment.
A New Trials Assessment Form (NTAF) (PCCTU example below) has a sample of questions that can be used. The Evaluation of a Clinical Trial as a Teletrial Checklist and Evaluation of a Site as a Satellite Site Checklist both contain a more detailed series of questions specifically about teletrials and should be used in conjunction with the NTAF.
New Trial Assessment Form PCCTU
Assessment of a Clinical Trial as a Teletrial QLD Health
Satellite Site Evaluation QLD Health
If a Primary or Satellite Site determines that they would like to proceed as a trial site based on their capability and capacity, a Site Selection Visit can be arranged.
The Sponsor will often visit the Primary and Satellite Sites for a Site Selection Visit (SSV). SSVs can be conducted remotely or in person.
It is recommended to provide the sponsor with all relevant documents prior to the SSV. The below email template by Maryanne Turner (PCCTU) can be used as a guide to the documents a site would need to provide and the questions they should ask.
Download: Template email to Sponsor prior to Site Selection Visit.docx
Once the Sponsor and Site have met and discussed any remaining questions, it is time to present the trial to your site's team.
After the SSV and once you have received satisfactory answers from your discussion with the sponsor, both the Primary and Satellite Sites should present the trial to their institutional colleagues for their consideration and endorsement.
Identify who will be involved in the practical implementation of the trial at your site.
This Clinical Trial Presentation tool has been developed by Maryanne Turner (PCCTU) and may be used as a basis for team presentations.
Download: Clinical Trial Presentation tool template.docx
Once approved internally at both the Primary and Satellite Site, sponsor approval is required.
You will need to receive a formal acknowledgement letter from the sponsor that your site has been selected to run the trial.
You will also require written agreement from the sponsor that the trial may be conducted under the Teletrials model.
The following study start-up checklist developed by Maryanne Turner and Diane Pitropakis (PCCTU) summarises the material presented in this module to aid project management.
Download: PCCTU Study Start-up Checklist
Once a trial has been accepted and the sites have been chosen, both Primary and Satellite Sites will need to set up a study-specific site file. Information about preparing a Site File is in Section 2: Site Readiness (Documents required to show a Site has Teletrial capabilities).