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Description of the Project
Sponsor, CRO and Site Responsibilities
Publication and Intellectual Property Terms
Indemnification and Insurance
Recording Keeping and Inspection
Guidelines for Dispute Resolution
Grounds for Contract Termination
Amendment of Contract Terms
1. Description of the Project
This section of the agreement is often overlooked by sponsors, CROs and sites. The
purpose of this section is to explicitly state the research project description. You
want to document the overarching purpose of the agreement in this section.
In the United States, with the Sunshine Act, there is an increased scrutiny on
payments made to health care organizations and health care professionals. The
project description provides the necessary details on the nature of the agreement.
In the event there is a compliance audit questioning financial payments to the
research site, the project description can provide clarity.
2. Payment Terms and Schedule
Sites want to get paid for their research services. In the case of a multi-year clinical
trial, sponsors and CROs want to manage their budget and expense projections for
current and future years.
This is where the payment schedule comes handy.
The payment schedule lists the project deliverables and expected payments for
each deliverable.
Additionally, in some cases, payments are triggered when certain milestones are
met. For example, once the site is activated for enrollment, a site start-up payment
is triggered.
The payment terms and schedule will also state what the research site will NOT
get paid for. For example, for a post-approval clinical study, the sponsor may not
want to provide the medical device for free.
Finally, this section of the agreement should clearly state where the site needs to
send invoices (name and contact information of the person), as well as the
payment terms (example: payment will be made within 45 days).
3. Sponsor, CRO and Site Responsibilities
It’s no surprise to us that clinical research is a regulated industry.
There is serious responsibility on the part of sponsors, CROs and sites to comply
with the study protocol, government laws and regulations.
The purpose of this section is to document that the research site will comply with
laws, the participating physicians and institution are qualified to conduct research,
and the institution will inform the sponsor of Institutional Review Board
(IRB)/Ethics Committee (EC) approval (or denial).
On the other hand, sponsors and CROs are required to notify the IRB/EC directly
of any non-compliance that could impact the safety and well-being of trial
subjects.
4. Publication and Intellectual Property (IP) Terms
A CTA must include the sponsor's take on publication and presentation of clinical
trial data.
Sponsors are committed to reporting trial results on ethical grounds. Clinical site
investigators, on the other hand, are excited with the idea of publishing research
data.
Generally speaking, sites have to wait for the entire study results to be released
before they can publish data on their subset of enrolled subjects. Also sites would
be required to submit the manuscript to the sponsor review prior to making a
journal submission.
This section of the CTA will spell out how many days the sponsor has to review
and comment on the manuscripts. Once the sponsor review period has lapsed, the
site can go ahead and publish the results.
The data from a clinical trial is owned the trial sponsor, unless the agreement
states otherwise.
5. Indemnification and Insurance
Indemnification may be a fancy word you’ve never heard before, but the concept
behind this term is fairly straightforward.
If a third party, such as a clinical trial subject, is negatively affected as a result of
the CTA that is between the sponsor and site, the sponsor will compensate for loss
and assume full responsibility.
There may be limitations to the indemnification language. For instance, the
sponsor may not agree to indemnify the site if it fails to follow the protocol or sells
subject personal health information (PHI) to a third party.
Just like your auto or health insurance policy, sites, CROs and sponsors generally
carry clinical trial insurance to protect themselves or the parties involved in a
clinical trial.
6. Recordkeeping and Inspection
Generally speaking, the purpose of a clinical trial is to collect safety and
effectiveness data on a given medical product.
But what happens if the clinical site provides incomplete or incorrect data to the
sponsor? Or is hesitant to allow a CRO to monitor the data at the site?
That’s where the recording keeping section of the CTA comes handy.
The purpose of this section is to document the agreement between the site and the
sponsor on how long the trial data will be stored for after the trial is completed
(typically two years at a minimum).
Additionally, this section includes other agreements, such as the sponsor's right to
audit the site or verify data on a regular basis, and the site’s responsibility to
cooperate with the sponsor or a regulatory agency, such as the FDA.
7. Guidelines for Dispute Resolution
What happens if the sponsor or the site has a dispute?
The purpose of this section to explain how issues will be escalated and attempts
will be made to resolve them through mutual resolution.
If either party to the agreement decides to take legal action, this agreement will
specify under which jurisdiction the case will be handled.
8. Grounds for Contract Termination
As sponsor and site, you want to prepare yourself for contract termination.
Below are some reasons for which contract termination may be necessary:
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Fraud
 Non-compliance with national, state or local laws and regulations
 Change in business strategy requiring the sponsor to terminate a trial early
 EC or IRB may determine the trial is no longer safe for the subjects
All parties on the CTA could be required to provide 30-45 day notice depending
on the reason for termination.
If agreed on a signed CTA, sponsors will have the right to data collected prior to
contract termination and sites will receive compensation for trial activities
performed by the research staff.
9. Amendment of Contract Terms
New and unexpected situations always arise.
Site may realize there is more work involved on a trial than they had anticipated.
Or sponsors decide to revise the protocol, which in turn impacts the milestone
payment schedule in the CTA.
Contract amendments are not fun. But they may be necessary. You want to have
provisions in your CTA that allow you to request for an amendment of contract
terms.