Negotiating contracts isn’t fun for clinical trial sites (or consultants). Contracts define the terms of how a sponsor and clinical trial site interact, who the parties are, and important issues for every clinical trial site to consider. One of the hardest issues for me has been indemnification; what to ask for and when to ask for it.
This Guest Commentary by Jill Petro helps to demystify some of the issues that clinical trial sites face when looking over a contract.Jill works for Aureus Research in New Orleans and has some practical issues for you to consider including checklists, spreadsheets, and templates.
Clinical Trial Contracts, by Jill Petro
Whether you are an Investigator, a study coordinator, a site manager, a CRA, or a member of the Contracts and Grants department, you probably have responsibility for some aspects of the contract and budget process. Most of us in these areas have had little, if any, formal legal or financial training. This is unfortunate, because the contract is the critical document that defines the expectations and legal obligationsof the Sponsor and Site (and sometimes the CRO).
Now you may say the protocol is more critical, but most contracts have a statement that the agreement supersedes with the protocol merely an attachment to the agreement. Shouldn’t we then spend as much effort making sure the contract is good for both parties as we do getting the protocol right? Reviewing contracts and budgets is time-consuming and can be frustrating.
This is NOT our area of expertise, and yet we are expected to negotiate asound agreement. It is possible to reduce the stress associated with this task if you develop a reasonable process forreview. This might include the use of checklists, templates, or spreadsheets.
ChecklistsIt’s not uncommon for Sponsors and Sites to have an “elements of the informed consent checklist” against which the Informed Consent Form for each study is compared to ensure none of the required elements are missing. Most Sponsors and CROs provide sites with a contract for review. The contract has probably already undergone a check of some sort by their legal staff. Wouldn’t it be nice for the site to have a “checklist of required elements” to use during the contract review process? This checklist will likely take some time to develop for a site. It should involve input from the Investigator, the Institution, the Site Manager/Study Coordinator, and Lawyer(s). All topics
that must be present should be listed and might include:
(A) Who the parties are,
(C) Subject injury, etc.
Now that the Site has its list of “required elements in a contract,” the group should decide on acceptable and unacceptable language within each topic. These could be your templates when reviewing a contract. If it matches your template (or the intent of your template), everything is fine. If it doesn’t, you have some template language which you can suggest as an alternative.
For instance, with regard to the parties, sometimes the contract is between the CRO and the site. If this is the case, your group would have to decide if this is acceptable or if it has to include the Sponsor. Maybe it would be acceptable if it says “CRO on behalf of the Sponsor,” but not if it is just says “CRO”. When it comes to indemnification, it is almost a universal expectation that the Sponsor will provide indemnity to the Site in some manner. It is likely that this will be a “required element” in the contract. As you discuss this area, your group will probably need to establish expectations on what will and will not be covered by indemnity.
Most Sponsors indemnify for njuries due to study product, but not for injuries caused by negligence. That seems straightforward enough, but what about indemnifying for a procedure that would not have been done except per study requirements? Next, your group will have to carefully check its insurance policies. Most contracts include a statement that the Site will also indemnify the Sponsor. Although some Sites may be able to extend their coverage to another party, many will not be allowed to do that by their insurance carrier. Check this out. If your insurance will not allow this, make sure your checklist includes this “Site indemnifies Sponsor” language in the “unacceptable language.”Our final example is subject injury. Consent forms must explain to the subject what compensation is available in the event of a research-related injury. In my experience, many contracts do not address this issue at all. To ensure all parties agree to their obligations in this area, the contract should include language that mirrors that of the informed consent form. A Site might also want details in the contract that explain how that process will work (how to request and obtain reimbursement).
Did I mention that this was a complex and lengthy process? It will probably take your site some time to develop its checklist and templated language, but it will speed up future negotiations. Why not make it one of your business resolutions for 2011 to bring this issue forward to those involved and try to have the task completed by the end of the year? It will make every contract easier in 2012!
Read about the Academy of Medical Research Report by Nick Taylor in Outsourcing-Pharma
UPDATE: There is a very interesting Important Notice to IRBs that is on the FDA website. Sort of a Coast IRB redux.
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