From the President by Julie Orr

Transcription

1 VOLUME 2 ISSUE 3 From the President by Julie Orr 1 From the President [by Julie Orr] 1 Rx for Risk [by Mike Robertson] 4 Notes to File Use and Misuse [by Andrea Marlow] Why do I need insurance? The pace at which we all work these days and the litigious environment in which we work are all reasons for prudent clinical research professionals to be aware of the need for professional and business insurance and up to date information on current requirements. Clinical trial lawsuits or claims can result from a variety of allegations including failure to perform per contract, failure to properly monitor, or failure to report adequate information. Having adequate and proper coverage is now essential for all parties involved in a clinical research study including project manager, study managers and clinical trial monitors. In an effort to help educate and provide valuable information to clinical research professionals, a multi-part series written by Michael Robertson of Knauff Insurance will be presented in our newsletters discussing various aspects of insurance needs for the clinical research professional. Check out the online version of modocresearch.com Rx for Risk Pharmaceutical Consultant by Mike Robertson Pharmaceutical consultants face many types of risk. Sometimes these consultants engage with much larger firms during a project. Their activity within the scope of the project can also vary depending on the engagement. They could be doing medical writing, regulation compliance, SOP work, etc. Hence, it is very challenging for these consultants to comply with the insurance requirements of the customer, as well as adequately protect themselves and be shielded from possible liability should a lawsuit arise. In some instances, the larger customer may require insurance coverage that is fiscally outside the reach of the smaller consultant. The consultant may be able to convince the customer to reduce the insurance required for a particular project. But how much insurance is too much? And what types of insurance are needed? And aren t these types of insurance cost-prohibitive? In order to answer these questions, it is helpful to discuss the different types of insurance a pharma consultant may be asked to obtain.

2 Rx for Risk Cont d Are You Attending DIA in June 2011? Come and Connect with Modoc! DIA is an important industry event and Modoc is looking forward to attending, learning, sharing and exchanging ideas. We d also like to connect (or reconnect) with our colleagues, team members and acquaintances from around the country. If you are attending DIA and want to connect, drop us a line so that we can schedule a time to grab a coffee and catch up. If you are interested in learning more about Modoc Research Services, then we d be happy to schedule a lunch meeting and presentation. Call us at or drop us a quick at [email protected]. General Liability A typical contract will almost always call for general liability insurance. This insurance protects the insured from 3 rd party liability lawsuits for bodily injury, personal injury (libel, slander, defamation, disparagement, etc.), property damage, automobile liability (use of personal vehicles to conduct consulting business), and other coverage. Limits required by the customer can range from a typical low of $1,000,000 per occurrence and $2,000,000 aggregate (total for the year), all the way to $5,000,000 or even $10,000,000 (usually using a liability umbrella). These higher limits are excessive within the scope of a typical pharma consulting project, and usually the customer will reduce those limit requests. A general liability policy always excludes any type of patient clinical contact (including study medication dosing and management). This exposure is addressed within medical malpractice policies for physicians, nurses, site management organizations (SMO s), Clinical Investigators (CI s), or Clinical Research Associates (CRA s). The general liability policy also always excludes other forms of Professional Liability, which could result from financial loss, breach of contract, warranty, or other similar perils. Several insurance carriers offer general liability insurance for pharma consultants. Professional Liability - As customers deepen their understanding of contractual risk, more of them are requiring professional liability (also called Errors and Omissions) insurance of their consultants. This insurance protects the customer against financial injury which could result if the consultant fails to perform certain key tasks designated in the contract. This type of coverage is more difficult to obtain, and requires a more thorough underwriting process, which includes evaluation of the contractual language or agreement between the customer and the consultant. Limits requested for this insurance are usually in the $1,000,000 - $5,000,000 range. For a small pharma consultant, it is usual and customary for the client to request $1,000,000 in limit. The premiums are rated per thousand ($1000) of annualized gross sales for the consultant, not just for a single contract. The contract is also underwritten for areas like liability limitation, exclusive remedy, consequential damages, force majeure, and other terms and conditions of the agreement. There are few insurance carriers who specialize in writing this coverage.

3 Rx for Risk, Cont d By Mike Robertson Workers Compensation Depending on where the work will be performed, the customer may require workers compensation insurance in compliance with respective state statutes. Most will require at least $500,000 and sometimes $1,000,000 in coverage. The rate for this insurance is based upon four digit class codes which capture the scope of the job being performed. Insurance carriers file class codes and rates with each state insurance commission where they hope to write this business. The rate is based per hundred ($100) dollars of payroll. In most cases, the class code for consulting type work is 8810 Clerical. Depending on the carrier, the rate could be cents per hundred of payroll. So, if a payroll exposure for a pharma consultant is $100,000, the base premium would be $300 for the year, assuming the lower rate, plus applicable state taxes and fees. It is important to note that customers have their own requirements for insurance as well. Typically, the sponsor of a human clinical trial will have to procure liability insurance to protect against bodily injury to patients during the study. If the client is a CRO (Contract Research Organization), they will have professional liability insurance requirements imposed upon them by their customers, who are typically sponsors of the trial. If the client is a medical device manufacturer or distributor, and they are post 510k approval, they will have products liability insurance requirements. A concluding word of warning should be said regarding Insurance Certificates. In most cases customers, clients, and some credentialing vendors may require the consultant to issue an insurance certificate. They may also require that the certificate specify that the client be named as an Additional Insured. This should be done cautiously, even though issuing the certificate does not convey any special rights under the policy form. Adding a client as additional insured is usually not an issue for most carriers providing the general liability policy. However, insurance carriers are generally unwilling to do this for professional liability policies. It is important to note that most client requests to change or modify the language on the certificate form cannot be accommodated. The Acord form is copyrighted, and cannot be changed. It is filed with eleven state insurance boards, and changing or altering the form is actually illegal (class 1 misdeameanor) in some states. So, these three areas of insurance general liability, professional liability, and workers compensation, are the most commonly required by the customers. They also provide the most important protection for the consultants, and are highly recommended. Finally, pharma consultants would be wise to make their insurance inquiries through a broker who has life sciences expertise, since they will be able to access the insurance carriers with the broadest coverage and least expensive rates. Next time, we will examine coverage issues for pharma consultants that are independent contractors, employees, or separate corporations. Mike Robertson CFE PPS Director Life Sciences & Technology Knauff Insurance [email protected] (Mobile)

4 Notes to File Use and Misuse By Andrea Marlow What began as an acceptable, explanatory tool for process and procedures has evolved in to an explanation and, as some have described, a panacea for all things gone awry at a research site. The now all too common practice of using NTFs to document deviant processes began when sites and monitors could not find an appropriate place to document certain issues. It is now too common a practice and the ramifications of documenting everything from a logistics issue explanation to a serious non-compliance issue are far-reaching. Notes to File (NTFs) or Memos to File (MTFs) can be very useful in identifying an issue and documenting a procedural change for process improvement. A NTF can also be extremely helpful in the explanation of a process not otherwise clarified. However, in recent times, the content of many of these notes has been found to be less than beneficial and in some cases, actually harmful to a site, especially during an audit. The NTF in itself is not indicative of a corrective action when it is generated to expose or document a problem. Some monitors and site personnel actually think NTFs are required and in some cases, these have been determined to have been thought of as essential documents. For the most part, adequate training of inexperienced personnel will reveal there is no required use of NTFs from a regulatory standpoint. What is commonly found at sites are numerous memos generated after a deviation has occurred, basically only documenting the omission or mistake, and not addressing the real issue with a resolution. In many cases, a NTF is written instead of what should be proper documentation in a progress note. In the event of non-compliance at a site, a NTF does not suffice for documentation but actually raises additional questions about site process and procedure. If issues are highlighted in a NTF without a documented proactive approach to their resolution and plan to prevent future repeat occurrences, what is really being accomplished? How often have we all requested a NTF and how often have we overheard a request for a site to generate a NTF, without any questions asked? Compliance issues will be observed from review of source documents and do not need to be front and center in another document that does not address the root of a problem or discrepancy, or correction process. Often the information contained in a NTF should be information found in a subject source document, a monitoring report or monitoring visit follow-up letter. If the NTF does not support the quality of a site s documentation or compliance with GCP, should it be generated? What is the purpose of bringing additional attention to missing or incomplete and incorrect data? In a Warning Letter dated October 23, 2007: ( tactions/warningletters/2007/ucm html) FDA wrote: "Our investigation found (the sponsor) failed to take any action except to generate numerous memos to file after all the subjects completed the study. Our investigation found that (the sponsor) failed to take any action to secure compliance while the study was ongoing except to generate numerous memos to the file after all subjects had completed the study. According to an FDA interview with (a sponsor) manager involved with (this study), these memos to file served as a mechanism to train the investigator. However, this same (sponsor) manager conceded that because the majority of these memos to file were generated after all subjects had completed the study, there wasn't much value in training the clinical investigator. We note that generation of numerous memos to file after all subjects have completed the study does not adequately secure compliance of an investigator. The Warning Letter then noted at least 89 memos were generated after a monitoring visit. Instead of writing NTFs, the sponsor's time is better spent qualifying the site and training study staff. Additional warning letters with references to NTF issues can be found on the Warning Letter tab of the FDA web site. We all may have a need to generate wordy explanations in a NTF, resulting from our need to provide a reason for why and how a deviation happened and to document it. The fact is that during the course of a trial, inadvertent, unintentional deviations from the protocol will occur. That is normal. They do not always need to be explained and analyzed in a NTF as long as the research personnel realize the error and ensure that it is not repeated. The critical part is to ensure training of all research staff, including monitors. The impact of the deviation is what needs to be communicated and understood. Pure convenience and a quick fix should not be part of the thought processes behind generation of NTFs. If we stop and consider the implications of overuse of NTFs, it should lead us to the realization that what needs to be instituted are improved documented standard operating procedures and corrective action/preventive action (CAPA) plans, to address deficiencies. STAY CONNECTED TO MODOC 24/7!

5 NEW FDA Guidance Document In May 2011 another new draft FDA guidance document was issued FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS. This draft is being circulated for comments. The intent of this guidance is to clarify existing financial disclosure regulations and to require submission of certain financial information with marketing applications that rely on clinical data. A copy can be located on Mozaic in the CTSS References FDA Guidance folder under the CTSS main folder. STAY CONNECTED TO MODOC 24/7! If you would like to submit an article the September Newsletter Deadline is August 31, Timesheets should be submitted by the 5th of each month. PO Box Wilmington, NC Phone: Fax: [email protected]