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Changes to Exempt Research
Recertification in a nutshell
Questions about Human Subjects Protection Training Certification or Recertification?
Responding in INSPIR to a Modification Memo
Training in Clinical Research

The IRB Executive Committee has recently changed the requirements for continuing review of Exempt protocols. Studies are determined by the IRB to be EXEMPT because either they are NOT HUMAN SUBJECTS RESEARCH or because they fit into one or more of the EXEMPT categories (listed in B1 of INSPIR).

New protocols that have been submitted to the IRB via INSPIR and determined to be EXEMPT will be reviewed and then "marked as EXEMPT". No further review will be required. Existing protocols (pre-INSPIR) must be converted to INSPIR and determined to be EXEMPT. Then once the progress report is reviewed and approved, the study will be "closed" and no further reviews will be necessary.

For complete details regarding EXEMPT research, please go to the IRB website. We have also posted there new instructions for completing the INSPIR application for EXEMPT research. These instructions tell you which sections of the INSPIR application must be completed for EXEMPT research. Also posted on the site is a slide presentation explaining EXEMPT Research.

To be recertified to do human research at BUMC, you must have correctly answered 75% of the total quiz questions from the Clinical Research Times issues 11/03 through 3/05. (No, you may not be recertified by taking the NIH on-line course again!)

All the past issues of the Times are available in the newsletter's archives. Each article takes about 10-15 minutes to read and complete the questions. There have been 15 articles, with 4 questions each, for a total of 60 questions. Therefore you must have 45 correct answers in your "Account" to be recertified.

You can easily review which quizzes you have not yet answered by clicking the "My Account/Login" button at top of the Clinical Research Times web page and then clicking "Review My Account."

For more details about recertification, who needs to be recertified, and what happens if you don't, click HERE.

You may not need to be recertified now, if your original certification was obtained after 7/01/04 or if you came to BUMC after 7/01/04. You will, however, need to be recertified in the next 2-year cycle.

Don't remember when you were certified? Check out our list of who is certified and on what date. If your name is not on the "certified" list, we have no record that you are currently certified to do human research at BUMC. If you do not find your name but have a training certificate, please fax that certificate to 617-638-7234. If you require training, please click here for more information about initial training.

Please see the new page on the IRB website with FAQs (Frequently Asked Questions) and all of the information that you need in one place!

If you have questions that are not answered in the information provided, please send an email to medirb@bu.edu and include your name and contact information. Thanks.

Please reply to each item directly in the modification memo reply text box. List all changes made to protocol, consent form, or attachments. Then make all changes that you have said you are going to make. Then submit.

Boston University's Center for Professional Education offers some courses in clinical research. Established courses include The Clinical Trial Process: Concept, Conduct, and Conclusion and Bioethical Aspects of Human Research. For more information on these courses and for dates, see the Center for Professional Education's web site.

New courses to be offered include:

• Writing and Filing an IND
• Establishing and Building a Clinical Research Practice
• Managing a Clinical Research Practice
• Identifying and Managing External Resources and Vendors
• Building a Clinical Research Department
• Project Management Principles

Writing and Filing an IND
April 25-26
Instructor: Helen Colquhoun, MD, CEO Pleiad Contract Research Organization

The Investigational New Drug (IND) application is critical to the successful launch of human trials in the United States. Understanding FDA expectations concerning the quality of IND submission documents and submitting applications that meet these standards is therefore crucial.

Successful INDs do not simply report information. They are organized to defend the logic of the work completed and proposed. INDs must provide a shared context so the FDA reviewer will know immediately the intended purpose of the work, the major research findings to date, and the important issues surrounding this research and the proposed development plan. This course brings the participant through the people, the process and the product known as the IND. Interactive exercises will expose the student to some of the key portions of the document that seeks to gain permission for a new product developer to begin the key step in its' path to approval.

• Introduction to Investigational New Drug Applications (INDs)
• Clarify Roles and Responsibilities
• Apply Principles of Good Scientific and Medical Writing
• Examine the Drug Development Process
• Clarify timelines and determine when studies can begin
• Develop a pre-IND activity/timeline up through to IND filing
• Outline General Requirements for INDs
• Ensure Proper Content and Format of INDs
• Implement Effective Methods for Record-Keeping
• Learn How to Work with FDA
• Examine the Consequences of Inadequate Documentation and Non-Compliance

Helen worked as a pharmaceutical physician at Syntex Pharmaceuticals for six years and than as an independent contractor for five years. In 2000 she and her business partner set up Pleiad, where Helen is CEO. Pleiad is an independent CRO, working with many different therapeutics and other lifescience companies. Helen provides medical input to clinical research projects (study design, protocol/investigational plan development, data interpretation, safety management and reporting), crisis management assistance and negotiations with regulatory authorities.

This course is ideal for participants from emerging biotech and pharmaceutical companies who are preparing for an Investigational New Drug Application submission and for physicians who are embarking on an Investigator Initiated study.

Establishing and Building a Clinical Research Practice
Scheduled for Fall 2005
Instructor: Lisa Becker, President International Drug Development Cooperative

A clinical research practice can provide numerous benefits to a medical practice. These benefits include new learning opportunities, enhanced community image, increased referral base, and improved practice revenues for the practitioner, as well as new treatment opportunities for the patient. A deliberate, business-like approach with appropriate personnel and space is necessary for a successful clinical research practice. All personnel should have a thorough understanding of good clinical practices. The purpose of this course is to explore the positive as well as the negative aspects of starting a clinical research practice, the requirements for getting the site started, finding the first study grant, and tasks to be anticipated during the conduct of a study.

Topics included are:

• Research Site Infrastructure
• Budgets and contracts
• Develop Case Report Forms
• Marketing the Site
• Study Start-up Activities
• Managing the Study Activities
• Hiring Clinical Research Staff
• Training Clinical Research Staff
• Quality Assurance
• Preparing for Audits

This course is ideal for allied health professionals and physicians who are considering or who have recently started clinical trials for either industry sponsors or independently as physician investigators.

Managing a Clinical Research Practice
Scheduled for Fall 2005
Instructor: Lisa Becker

Participating in clinical research is the first step on a potential growth pathway for sites. But once the site is managing a few clinical trials there are new opportunities and new challenges that are different from medical practice issues. This course expands upon the prior course for the practitioner or manager who is in a growing clinical trial unit or practice. It provides practical business management skills with a focus on the clinical trial center with its unique issues.

• Planning site logistics & constructing timelines
• Estimating staff requirements and hiring the right people
• Understanding the roles and responsibilities of each member of the clinical research group
• Developing the budget for a clinical research practice
• Understanding and managing institutional overhead
• Targeting the appropriate study populations & developing patient recruitment strategies
• Ensuring facilities are adequate to support clinical research
• Data management -- setting up a data coordinating function
• Creating the regulatory function at the study site
• Reporting and managing serious adverse events at the clinical site
• Managing the financials to ensure viability of the practice

About the Instructor: Lisa Becker has 20 years experience in health care leadership, with five years focused on direct patient care and public health research, and fifteen years (bio-) pharmaceutical industry experience in clinical development, marketing, sales, training, and international operations. She has started up clinical trial units and applied business principles to academic research settings with excellent outcomes.

This course is ideal for clinical research coordinators/managers and physicians who are increasing and expanding their practice further into clinical trials for either industry sponsors or independently as physician investigators.

Identifying and Managing External Resources and Vendors
June 6-7, 2005
Instructors: Kate Didio, Director, Clinical Monitoring Management and Molly Rosano, Associate Director, Clinical Project Management, Sepracor

For sponsor companies, and particularly small pharmas and biotechs, the key to effective outsourcing is establishing enough process to allow sound decisionmaking, effective contracting, and strong CRO management, without hindering the agility, speed, and ingenuity on which such companies thrive. With the resource constraints these companies face, the other trick is to take time away from the critical day-to-day tasks to design a process that will save time in the long run. This workshop helps you to understand and develop an outsourcing program that give you the best value for your time and effort-even when your available time is limited. The workshop also identifies and address issues such as process leadership, buy-in and compliance, control, and oversight. Our workshop leaders focus on two areas when evaluating and implementing sourcing processes:

• Planning and Strategy for Outsourcing Activities
• Responsibilities & Accountabilities
• Studies and Activities to be Outsourced
• CRO Selection Process
• Request for Information
• Capabilities Presentation
• Sponsor Audit
• Proposal Review & Evaluation
• Contract Negotiation & Award
• Managing CROs
• Study Set-up, Planning, and Initiation
• Communication Plan
• Training
• Regulatory & Legal Requirements of CROs
• Critical Phase Monitoring
• Sponsor / CRO Communications
• Estimated Time and Effort for CRO Monitoring
• Study Reports
• Co-monitoring
• Auditing / GCP Compliance
• Changes in Scope
• Contingency Planning
• Selecting & Managing Other Vendors
• Central labs / safety vendors
• E-Pro vendors
• Patient Recruitment Vendors

This course is for professionals in biopharmaceutical and medical device companies who will be using external vendors to assist them with clinical trial management and execution.

Building a Clinical Research Department
June 13-14, 2005
Instructors: Laurie Halloran, Lisa Becker

A significant need exists within the biopharmaceutical industry for Clinical Operations management skills. Clin-Ops Management Professionals are responsible for both department and performance standards and quality, resource and budget planning and training and development responsibilities within many companies, large and small. The common career path for management within clinical research is promotion of a CRA from a technical position into either a Clinical Operations Management position or a Project Management position.

No training and education exists for the CPM role beyond supervisory skills training, unlike the PM training programs now widely available. Therefore, there is a shortage of qualified candidates for entry-level CPM positions within industry.

This course introduces the participants to the roles, responsibilities and demands that Clinical Operations Managers/Directors may encounter upon taking a position described above, as well as the skills, knowledge and experience necessary for starting a clinical operations role within an emerging or established biopharmaceutical company.

• The Clinical Research Team and How Clinical Operations Fits In
• Operational Planning in Clinical Research-The Critical Factor for Success
• Determining Roles and Responsibilities
• Resource Allocation and Management
• Outsourcing Strategies
• Financial Consolidation and Budgetary Planning
• Quality Systems
• Standard Operating Procedures
• Processes and Standards
• Key performance indicators
• Training and Development
• Using Technology to Increase Clinical Research Efficiency
• Clinical Supplies Units

This course is targeted toward biopharmaceutical and device executives considering the establishment of clinical operations to improve their development organizations and seasoned clinical research professionals who are considering or have recently made a change into a position in clinical operations.

Project Management Principles
Dates TBD-before end of June
Instructor: TBA-Gina

This 5-day course provides an overview of project management concepts and principles using lecture and discussions. An integrated new product development case study will provide students with a first-hand opportunity to practice the theories and concepts discussed in the classroom throughout the course. This course is 100% compliant with the Project Management Institute's (PMI) current Project Management Body of Knowledge. (PMBOK). Challenges inherent in the high-risk new product development business are the managing risk and controlling the project. Project managers should be critically examining their approach to managing risk. To remain competitive, projects cannot afford to set up contingencies or control measures for every conceivable risk. Rather, project managers must adopt a "graded approach" to managing risk. This course introduces learners to widely accepted risk assessment, management and control practices using tools and techniques.

• The Project Management Framework
• The (9) Knowledge Areas, the (5) Process Groups, and the Iterative Process Model
• Processes in Project Management
• Key Stakeholders
• Types of Organizational Challenges for Project Management
• Project Quality
• Risk Management Planning
• Risk Analysis and the "Graded Approach"
• Evaluating Potential Risk Probability and Impact
• Analyzing Risks
• Building a Risk Response Plan
• Selecting Project Control Tools