The Office of
1109-A Bioinformatics Bldg.
130 Mason Farm Rd.
CB 1651
Chapel Hill, NC 27599-1651
919-843-2698 ph
919-843-2399 fax
We have invited a representative from the industry to give their view of clinical trials from the "other side." Topics to be addressed include tips for source documentation, good monitor/coordinator relations, and industry expectations of sites.
Delays in enrollment are the single most costly issue in drug development. As a result, drug companies and CRO's place importance on recruiting suitable subjects in the shortest amount of time. During this session, strategies to increase recruitment and encourage retention will be explored.
Attendees will become familiar with various clinical trial and informed consent glossaries to aid in simplifying informed consent language. We will review and revise sample informed consent language and discuss expectations of comprehension.
We will review and discuss a current topic in clinical reserach. Topic will be sent to the listserv 2 weeks prior to the Lunch-n-Learn date. If you have ideas for Hot Topics, please call 843-2333.
This interactive session will discuss cultural influences impacting minority recruitment. We will describe culturally appropriate strategies to increase minority participation in research and invite participants to develop practical action plans to increase minority recruitment in current and future studies.
Sometimes working together in harmony is difficult, especially under stressful situations. This presentation will be offered by an outside facilitator who will help us understand various personality types and teach us how to handle "seemingly' difficult people.
This will be an informational session presented by a member of the IDS staff. Please bring any questions you may have about IDS forms, times of submission, and potential policy changes.
This will be an informational session presented by an IRB representative. Individuals will receive the latest updates/requirements from the IRB. Representatives will be available answer questions concerning application submissions, approvals, safety reporting, etc.
This session will guide you through your regulatory binder from study start-up to study close-out. We will discuss tips on how to ensure your binder is up to date.
This workshop will focus on the financial aspects of clinical trials. The workshop will consist of small group discussions and hands-on activities. Activities will include analyzing the sponsor's budget, identifying hidden costs and developing an internal budget. Feel free to bring specific budget issues with you.
This two-part series will be conducted as two four hour sessions held one week apart. The intent is to introduce new CRC's to the history of clinical trials; the federal and local regulation governing conduct and provides an overview of how clinical research is conducted at UNC-Chapel Hill. This program is strongly recommended for all new CRC's.
Informed consent is more than just a document; it is an ongoing process that starts at enrollment and lasts the duration of the subject's participation throughout the trial. At this session we will examine the consent process, writing the consent document, and understand how to assess subject comprehension throughout the trial. We will review informed consent forms for Registries, Genetics Studies, and Social Research Studies.
This course will provide the department administrator with a working knowledge of clinical trials from study start-up to closure. We will provide an introduction to the phases of clinical research and the regulatory framework that governs clinical trials. Learn the role and responsibilities of the study team, and how to process a trial through the UNC system from start to finish including financial management from OSR's post-award perspective. This workshop is appropriate for administrators of all levels of skill who desire to learn more about the conduct of clinical trials.
This session is for the new coordinator who desires to do their job better by grasping a deeper understanding of the regulations. This Good Clinical Practice workshop will provide a comprehensive review of the principles of the ICH Good Clinical Practice Guidelines as they apply to the conduct of clinical trials. The workshop is specifically targeted for those who actively work on clinical trials in a hand-on role as a clinical research coordinator. The concepts in this workshop focus on the history of clinical trials, application of the regulations to practice, and specific techniques that will help in conducting clinical trials according to Good Clinical Practice including adequate source documentation and adverse event reporting.
The old adage "If it was written down, it didn't happen" carries significance in clinical research. Source documentation not only proves that your subject exists; it also is proof that the trial was run in compliance with the protocol and contains the data that the FDA will review during the drug approval process. Therefore, it is imperative that source documentation is accurate and complete. At this workshop, we will discuss good source documentation techniques and offer examples of both good and bad source documentation practices.
Contracts for clinical trials contain language that dictates not only how the trial is to be conducted but also contains clauses that describe the legal oblications of the Prinicpal Investigator and the study team. Learn how to read a clinical trial agreement and how to identify your obligations.
This session will take the GCP's to the next level. We will explore how GCP's apply to your practice. Case studies, articles and current events as they relate to the conduct of clinical practice will be discussed. This session will be limited to 25 participants so that we can foster small group discussion.
Are you familiar with federal guidelines regarding AE reporting? What about local IRB requirements? Can you differentiate between an adverse event and serious adverse event? What are adverse drug reactions and how are they reported? What is the difference between seriousness and severity? We will explore and discuss adverse event reporting requirement for the site and the sponsor.
This session for new coordiinators will focus on starting a new study at the investigator site. We will discuss all of the key players in clinical research (site, sponsor, and CRO) as well as their roles and expectations. We will also discuss internal university processes.
This session will focus on developing a site study budget at the start of a study. We will discuss the importance of the schedule of events as well as how to account for CRC and PI effort on a study.
Do you know how the regulations define Electronic Records or what is actually considered an electronic record? Do you know the proper University procedures to follow whena monitor comes to verify source documentation and request access to electronic records? We will discuss the regualtions as well as University procedures for accessing and protecting electronic records.
In this session, we will discuss how Investigator-initiated projects differ from Industry-sponsored trials. We will review the role of the sponsor-investigator as well as discuss contractual and financial obligations.
This session is for administrators and advanced coordinators who may have financial responsibility of managing clinical trial budgets. After the budget is developed and funds received, how are are the funds managed? We will discuss a new financial management tool which aids in managing/tracking subject visits, invoices, and payments. This session will be limited to 25 participants in order to foster small group activities.
In this session, we will discuss the challenges of multi-site trials. What are the contractual and financial obligations? How are the data handled and what about managing personnel? This workshop will discuss issues surrounding coordinating multi-site trials.
This workshop will focus on the importance of the clinical trial protocol and how each section relates to other clinical trial activities such as developing clinical study plans/check lists, informed consent, budget development, data collection, and contract negotiations.
How do you assess the performance of your research unit? Do you have standard operating procedures (SOP's)? Are you sure that source documentation is done in a way consistent with your SOP's? This workshop will discuss strategies for establishing an internal QA program will help to ensure that your site provides quality data that will stand up to an audit.
You have worked hard to recruit your subjects and provide quality data to your sponsor. To reward you, the sponsor has told you that you are now subject to an internal audit by them and you will likely be the subject of an FDA audit as part of the Bioresearch Monitoring Program. No need to panic — attend this session to find out what to expect and to hear the experiences of others who have survived their own audits.
The OCT has identified three educational tracks to guide interested participants in determining what sessions are appropriate for their position and level of experience. Please note that the tracks merely offer guidance. All session are open to everyone.
This series was designed for the coordinator with less than 2 years clinical research experience. Individuals may be new to the University with limited knowledge of clinical trial conduct, good clinical practice, regulations and common terminology associated with clinical research. Course examples include:
This series targets the experienced CRC with more than 2 years of experience. These individuals will have a fair understanding of University policies and procedures, are very familiar with conduct of clinical trials, possess adequate understanding of GCP's and is able to apply to current practice. Course examples include:
This series focuses on introducing clinical trials to the department administrator. While the coordinator series focuses on the actual conduct of clinical trials, this series focuses more on the administrative processes behind implementing a clinical trial. Course examples include:
Please call the OCT at 843-2698 with any questions.