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.
Guest Commentary
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.
Checklists
It’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 topicsthat must be present should be listed and might include:
(A) Who the parties are,
(B) Indemnification,
(C) Subject injury, etc.
Templates
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!
Aureus Research Consultants, LLC
=============
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.
On the Blogroll: Diabetes Self Management, well organized and informative
=============
Please join GxP Perspectives on LinkedIn at:
GxP Quality- Building a Culture of Compliance
January 24, 2011Building a Culture of Compliance
This will be the last post for two weeks as I go traveling for a bit. I wanted to let readers know of two important recent articles (with links at the bottom of the post.)
The first is about a report issued earlier this month by the British Academy of Medical Sciences. The report was commissioned by the British government to try to pare back some of the bureaucracy involved with clinical trials in the U.K. An article on the report by Nick Taylor in Outsourcing-Pharma there are some interesting revelations about the British regulatory agency, MHRA. I strongly recommend reading this article.
In addition, I would like to refer readers to last week’s FDA Matters for interesting issues of concern at FDA. Now, here are Len & Emma:
Guest Commentary by Emma Barsky & Len Grunbaum
Implementing a “Culture of Compliance”: Practical Steps
Establishing a “culture of compliance” is not a “paint-by-numbers” exercise; it must be injected into the DNA of a company. In our experience, many companies strive to create a “culture of compliance” but few approach it from the perspective of a mindset of “shared attitudes, values, goals and practices that characterizes an institution or organization,” which is the essence of a “culture.” The ideas that follow are intended to provide a roadmap and practical steps towards implementing a company-wide “culture of compliance” in the life science industry, across any GXP area.
1. Develop a quality policy statement and quality objectives
Developing a Quality Statement
2. Identify and document quality criteria
Company management should identify and document the criteria for “good quality practices.” These components may include, but may not necessarily be limited to, adherence to written policies and procedures, exercising good documentation practices (e.g. initialing and dating cross-outs, using a single line to for corrections), promptly bringing any deficiencies and/or deviations to the attention of company management, documenting unplanned deviations, providing explanations/justifications when planned deviations occur and correcting them in a timely fashion.
Defining Expectations for Quality
3. Establish a robust quality baseline
Through performing internal audits and assessing CAPAs, the company’s Quality function (e.g., Quality Assurance) should identify quality-related issues based on the criteria regarding the components of “good quality practices” outlined in item number 2.
While performing the internal audits and through capturing the findings in the CAPA system, the Quality function should focus on identifying trends and themes related to non-compliance. In order to achieve this objective, the company’s CAPA system should be such that it allows the company to collect information regarding appropriate metrics to assess the success of the “culture of compliance” initiative.
Lack of compliance should be tracked not only on an issue-by-issue basis, but also across departments, individuals and operations/processes. Collecting information on these items will help to identify the root cause of the issue, which may stem from a larger issue related, but not necessarily limited to,
1. Cumbersome and, therefore, ineffective processes
2. Lack of appropriate supervision
3. Procedures that lack clarity (e.g., poorly worded documentation; lack of guidance, contradictory information)
4. Lack of documented procedures
5. Lack of an individual’s attention to detail and common sense
6. Lack of effective training
The list of potential root causes of the deficiencies encountered is limitless, but one thing always remains clear: unless quality-related issues are addressed and remedied at the root cause level, the fix to compliance issues will not be permanent, nor will the company be able to create and maintain the “culture of compliance.”
4. Maintain a robust quality baseline
Every internal audit should focus on the effectiveness of the established CAPA system. Specifically, the Quality function should determine whether:
1. The nature and impact of the deficiency on data has been properly identified
2. Effective corrective and preventive actions have been implemented
3. Appropriate follow-ups have been performed
4. The system is robust enough to trend and track quality-related issues accurately and completely
5. The system is robust enough to identify weaknesses with processes, documentation practices, personnel, etc.
The company’s Quality function should investigate all instances where the above has not been achieved for improvements within the quality system. This includes the defined metrics of the CAPA system.
In conclusion, we would like to emphasize that many factors, including but not limited to, new staff, acquisitions/mergers, new lines of business, staff reductions and/or new management have an impact on the “culture of compliance.” Therefore, in order to be successful, a “culture of compliance” should be a “living” initiative, which is constantly assessed for its effectiveness in light of changes that every company experiences during the normal course of events.
Emma Barsky
Len Grunbaum
Partners
The Practical Solutions Group, LLC
=============
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.
=============
Please join GxP Perspectives on LinkedIn at:
GxP Perspectives LinkedIn Group
See the page Guest Commentaries (at the top of the blog) for the previous article by Len & Emma on Part 11 compliance.
On FDA’s Website there are Two New Warning Letters from FDA to Clinical Investigators that show the need to effectively respond to a Form FDA 483, Inspectional Observations, with a well thought out CAPA Plan.
Share this:
Like this: