Compliant Clinical Research Conduct: What Every Clinical Research Professional Needs to Know
Jennifer Holcomb, Clinical Research Expert
Coming soon.. Please contact customer care for new schedule
The many regulatory agencies charged with oversight of Clinical Research have exacting requirements to ensure the protection of study participants; and while there is overlap in goals there are differences in expectations and standards. The complex regulatory environment can be difficult to navigate, but understanding it is a necessity for all clinical research professionals. Compliance with all of the various regulatory requirements ensures safety of patients, quality of data and timeliness and efficiency of study completion. Historically clinical research has been carried out as a secondary interest of physicians, often by coordinators with little or no experience. Today, the standards for the professionalization of clinical research roles continues to grow through the certification of research professionals. Robust educational programs, such as this seminar form a solid foundation of principles needed for success as a research professional.
- Differentiate between the regulations that apply to FDA-regulated studies and those that apply to federally- funded studies
- Define research with human subjects
- Describe the typical activities and flow of a study
- Describe different types of human subjects research
- Define research misconduct
- Describe the standard items addressed in a clinical trial agreement (CTA)
- Describe Conflict of Interest (COI)
- Identify key components of good documentation practices
- Outline various safeguards for ensuring data integrity
- Summarize the IRB scope of responsibilities and authority
- Demonstrate the principles of confidentiality and privacy in all clinical research operations
- Apply the key regulatory requirements and good clinical practices that apply in the protection of human subjects during the informed consent process
- Apply the applicable regulations in the clinical research professional's role of identification, documentation, and reporting of Adverse Events and Unanticipated Problems
- Recognize and take appropriate action when noncompliance is suspected or observed
- Describe the compliant process for evaluating study billing
Seminar Fee Includes:
USB with seminar presentation
Hard copy of presentation
$100 Gift Cert for next seminar
Who will Benefit:
- Healthcare providers interested in exploring the field of Clinical Research
- New Clinical Research Coordinators (1-2 years)
- New Principal Investigators
- Administrative managers in charge of Clinical Research
- Regulatory Compliance Associates and Managers
|Day 1 (8:30 AM – 4:30 PM)
||Day 2 (8:30 AM – 4:30 PM)
- 8:30 – 9:00 AM: Registration
- 9:00 AM: Session Start Time
- Overview and Introductions
- Understanding Federal Regulations and ICH GCP (International Conference on Harmonization- Good Clinical Practice)
- Determining when an Activity Qualifies as Human Subjects Research
- Types of Human Subjects Research
- Comparing Drug and Device Development
- Understanding the Lifecycle of Clinical Research
- Start Up
- Study Conduct
- Close out
- Understanding Roles and Responsibilities and Ensuring Compliance
- Regulatory Requirements
- Conflict of Interest
- Research Misconduct
- Audits and Inspections
- Understanding the Approval Process
- Document Preparation
- Working with IRBs (Institutional Review Boards)
- Understanding Study Conduct, Documentation and Reporting
- Source Documents
- Regulatory Files
- Informed Consent
- Adverse Events
- Privacy, Confidentiality and HIPAA
- Understanding Agreements: CDA, CTAs, Grants
- Cost Planning and Budgeting
- Understanding Clinical Research Billing
- The NCD (National Coverage Decision) and Third Party Payers
- Charge Assignment Grids
Meet Your Instructor
Clinical Research Expert
Jennifer Holcomb,MA, CCRC, is a clinical research professional with 20 years of experience in the field. Currently employed by UCHealth, she provides guidance and leadership in the establishment and development of policies in the conduct and management of clinical research. Key areas of expertise include clinical trial budgeting and contract negotiations as well as regulatory knowledge including international ICH GCP standards. Jennifer has extensive experience in training and education and served as Vice Chair of the ACRP Professional Development Committee for 4 years ending in December 2013.
Register by P.O. / Check
Yes, I want to attend "Compliant Clinical Research Conduct: What Every Clinical Research Professional Needs to Know".
Click here to download P.O. form
If you are paying by check:
Checks should be payable to MetricStream Inc. (our parent company) and mailed to:
2479 East Bayshore Road
Palo Alto, CA 94303
Send your team for maximum benefit.
Get your team up to speed!
Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.
||Get 10% off
|3 to 6 Attendees
||Get 20% off
|7 to 10 Attendees
||Get 25% off
||Get 30% off
Call toll free on +1-888-717-2436 if you have any queries.
Register by Wire Transfer
If you wish to pay by wire transfer, please call us toll free on +1-888-717-2436
Terms & Conditions to Register for the Seminar/Conference/Event
Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ firstname.lastname@example.org
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).
Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days before the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.
Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.
If you wish to partner with us for this event
contact us: email@example.com
call us: +1-888-717-2436.
Media Partner Benefits
- Logo and company data on the event website.
- Logo on the conference material distributed during the conference.
- Media partner’s brochure distributed along with conference material.
- Logo on all the mailings before and after the event.
- 10% discount to media partner's subscribers.
Media Partner To Do
- Banner (min 728x90 or 468x60) on the media partner website.
- Insertion of the event in the event calendar, both printed and/or online.
- Announcement article of the conference on the magazine and/or website.
- Dedicated email blast to media partner’s subscribers.
- Article on the magazine and/or website after the conference.
If you wish to sponsor this event
contact Cruise Webster: firstname.lastname@example.org
call us: (207) 576-4173
San Diego Cabrillo National Monument
The first European to set foot in California was the Spanish explorer Juan Rodriguez Cabrillo, who stepped on shore near this spot in in 1542. He's the guy they made this statue to look like - and named the park after. We don't know if Cabrillo climbed all the way up to the top of this promontory or not, but people who make up here nowadays get some of the best views of San Diego, looking across the Bay and back toward downtown.
Sea Creatures at Birch Aquarium
Birch Aquarium is north of San Diego in La Jolla. It's not as big as some of the other aquariums in California or as flashy as the big sea-themed park down the road, but instead just right, filled with interesting exhibits and home to leafy sea dragons like the one above, creatures so improbably they look more like something from a children's book than from the ocean.
Legoland theme park takes its inspiration from Lego toys, those cute little bricks that snap together to build all kinds of fun things. It's one of several Legolands worldwide.
San Diego Zoo Safari Park
The San Diego Zoo's sister park offers a different kind of animal experience. Its name (Safari Park) is the clue and it indeed offers a more safari-like experience. Lots of large animals live in the same big, open areas here - predators kept away from prey, but otherwise much as they would in their natural habitat.
Coronado isn't really an island but a peninsula - a fact that doesn't get in the way of the name most people use for it. Whatever you call it, it's on a slender strip of land between the San Diego Bay and the Pacific Ocean, barely a few blocks wide. What it lacks in size it makes up for in fun, with a beach that's been named among the best in the country, a classic hotel and a compact, lively little downtown. Coronado's laid-back temperament makes a nice break from the busier parts of San Diego across the water.
Originally built for temporary use during the 1915-16 Panama-California Exposition in San Diego, Balboa Park boasts buildings beautiful enough to be considered attractions in themselves, especially if you're a photographer. They're surrounded by trees, lawns and fountains, but that's only the beginning.
In Spanish, La Jolla means "the jewel," an apt name for a pretty, Mediterranean-style seaside town - sitting on cliffs flanking the ocean.
La Jolla visitors like to shop and eat in the nice restaurants, some of them with lovely ocean views. There's a lot for the active visitor, too, including ocean kayaking, tide pool-hopping, surfing at Windansea Beach, biking or running along the waterfront.