2016 ICRM CRM Exam Prep Product Material. Part 6: Sample Business Case

Transcription

1 2016 ICRM CRM Exam Prep Product Material Part 6: Sample Business Case

2 Pharma Testing Company (PTC), Inc. Topic: Comprehensive Records Management Subtopics: Compliance, Litigation, Storage, Record Retention CURRENT BUSINESS SCENARIO: You have been hired as a RIM consultant to Pharma Testing Company (PTC), Inc. by the Vice President for Operations. You were hired because you previously worked with several pharmaceutical companies on RIM program implementations. Your knowledge of the regulatory environmental around pharmaceutical testing is one of your strengths. In your first meeting the VP indicates that PTC runs clinical trials for pharmaceutical companies in four different countries. There are two research centers in each country, one focusing on animal testing and the other human clinical trials. PTC must be able to produce study records for any drug (animal or human tested) upon request by the regulatory agencies for any country where the drug is under review or is approved for use. The VP informs you that recently a pharmaceutical company contacted them about producing records related to a series of studies completed more than 15 years ago for a specific drug currently on the market. The drug was under investigation by several regulatory agencies. These studies occurred in six of the eight total research centers, and only two sites (both human study sites) were able to produce the records for regulatory review. As a result of this, the regulatory agencies removed the drug from the market and fined the pharmaceutical company. The pharmaceutical company filed a lawsuit for breach of contract and cancelled all current projects assigned to PTC, Inc. PTC, Inc. will need to produce records from all previous studies or they will face additional legal action. The VP indicated there was no central management of records and each research center was responsible for the records of studies they conduct. The VP asks you to review the management of records at each location, and prepare a report with a proposal to develop a full functioning RIM program for PTC, Inc.

3 FINDINGS: You visit with the PTC general counsel to learn more about the requirements of the pharmaceutical company s contracts in regards to record retention. The attorney explains they never negotiate with the pharmaceutical companies on the storage of records and the contracts are very vague about how long to keep records, often referencing different regulatory requirements and then indicating the requirement to obtain permission from the sponsor to destroy. The attorney tried to get approval when negotiating contracts to add language specific to retention of the records and funding for secure storage of the records. The leadership and the researchers in the centers said that this could make the pharmaceutical companies go to another testing company or to universities to do studies, thus damaging the income of the company. The general counsel hopes that your report will include a section about the need to set some basic ground rules and request funding for records storage in the contracting process, especially if the retention is more than a decade. While visiting the human subject sites, you find most of the researchers and staff know records should be maintained until the sponsor (the pharmaceutical company) releases them. But there is little organization of where records should be stored. The centers use basements to store records once a study is complete. The clinical trial coordinator boxes up the paper records and puts the study number on each box and has them taken to the basement by the facilities staff. Facilities place the boxes on top of one another, sometimes directly on the floor or on pallets. There is no inventory of what studies are in the basement, no shelving or the ability to see past the first row of boxes. Some of the clinical trial coordinators scan all the records and store them on removable drives, CDs/DVDs or desktop hard drive. The company outsources IT support for setting up desktops, but does not have any shared server space or back-ups of information in the centers. is outsourced to a large international company who provides and shared storage. When staff leave the company, their desktop is handed over to the person who takes their job. The new person is told to clean-up the hard drive or any data on the computer they feel like they don t need. One site has a clinical trial coordinator who after entering data into the sponsor s data repository destroyed all the records of the participants, as she said the sponsor has everything. Records in the animal research areas are kept very similarly, in basements, on hard drives or removable storage devices. Much more is kept electronically as most labs have very expensive lab computing systems that produce reports of the tests on biological specimens. The electronic

4 storage of the data is haphazard depending on the personal organization of the lab manager or the lab tech performing the tests or managing the study. At all locations, staff agree that guidance or a policy on records storage should be in place, as well as better storage options for paper and electronic records. Staff says this should come from the company management. Each research center is funded by the study funds received for the work they do, and these funds are insufficient to cover the costs of records storage for decades or central and safe electronic systems. Centers have asked for additional funding for servers and storage devices that are more secure, but are told they need to cut their costs. They say they are doing the best they can with what they have. The central leadership offices have a database of all the studies stored on a server including which research center is assigned to each study, what funding they receive and status of the study. This is on a server only accessible to the leadership who provide printed or PDF reports to the centers on their assignments and budgets. The database managing clinical trials is one you have used before with another pharmaceutical company. ACTION: This business case has been designed to assess your proficiency in outlining problems and potential solutions. Write a clear, well-organized narrative business case that can be presented. Your business case should address evident problems and propose outcomes. Your business case will consist of two parts: an Executive Summary and an Analysis. The Analysis consists of several sections that will require a discussion of the problems and your proposed outcomes. I. Executive Summary 10 points maximum Explain (no more than 2-3 paragraphs) the basic overall problem(s) that you have identified, the key issues or factors that must be resolved, and a high level description of your proposed outcomes.

5 II. Analysis: 40 points maximum This section should deal with the specific problems and issues discovered during the study of business case scenario and findings. Your business case may contain lists, so long as the section includes a paragraph explaining why the actions are appropriate. Your business case may not consist only of lists, and should address the following sections. A. Identification of the Problems 15 points total Identify the critical RIM issues and discuss issue surrounding the management of records at PTC, Inc. B. Recommendations 25 points total Describe the recommendations you propose that should be taken to improvement the management of records at PTC, Inc.