Speaker Bio: Jackie Boyd is a Research Clinical Trials Nurse with the University of Louisville. She currently coordinates the K-PIRC (Kentucky IDeA States Pediatric Network Center), the site of the IDeA State Pediatric Network.
Contributors: Jackie Boyd, RN, BSN, CHPE, CCRC
Knowledge Gap:
The purpose of this activity is to educate healthcare providers with the most up-to-date information on properly using the Manual of Operating Procedures (MOP) while conducting clinical trials.
Target Audience:
The target audience includes all healthcare professionals such as physicians, nurses, pharmacists, and allied health professionals who would like to learn about using and applying the MOP during a clinical trial study.
Program Overview:
The purpose of this activity is to educate medical professionals on using the MOP and applying it while conducting a clinical trial.
Release and Expiration Dates
08/05/2020 – 08/05/2023
Objectives:
Define the MOP (Manual of Operating Procedures) and its scope
Explain the purpose of the Table of Events
Combine the protocol and the MOP to effectively create source documents and worksheets
Understand how to use the protocol and MOP to plan and implement complete study visits.
References:
Protocol: https://hub.ucsf.edu/protocol-development
MOP: https://www.nia.nih.gov/research/dgcg/clinical-research-study-investigators-toolbox/startup
Parts of your MOP: https://www.nia.nih.gov/research/dgcg/clinical-research-study-investigators-toolbox/startup
VDORA1, ESC, and Duke POP01 study protocols were used as examples for this presentation.
Speakers: Jackie Boyd, RN, BSN, CHPE, CCRC
Planners: Jessica Snowden, MD; Jeanette Lee, PhD, Lora Lawrence, RN; Catrice Banks-Johnson, MPA; Dana Shaw-Bailey, M.Ed.; DeAnn Hubberd, MA
Peer Review: Carol Sikes, MScN; Bonny Kenney, BA
Speaker Disclosures:
The planners, speakers, moderators, peer reviewers, compliance specialists and /or panelists of this CE activity have no relevant financial relationships with commercial interests to disclose.
Instructions to obtain credit:
1. Launch the activity
2. View the module
3. Take 1 post-test at the end
4. Complete Evaluation and Print certificate
ANCC Credit Designation Statement:
The University of Arkansas for Medical Sciences designates this enduring material for a maximum of .25 ANCC contact hours. Nursing contact hours will be awarded for successful completion of program components based upon documented attendance and completion of evaluation materials.
ACCME Credit Designation Statement:
The University of Arkansas for Medical Sciences Office of Continuing Education designates this enduring material for a maximum of .25 AMA PRA Category 1 Credit(s)TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Accreditation Statement (Direct Provider Statement)
In support of improving patient care, the University of Arkansas for Medical Sciences (UAMS) is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
Disclosure Policy Statement:
It is the policy of the University of Arkansas for Medical Sciences Office of Continuing Education to ensure balance, independence, objectivity & scientific rigor in all provided; jointly provided educational activities. All individuals who are in a position to control the content of the educational activity (course activity, directors, planning committee members, staff, teachers, or authors of CME) must disclose all relevant financial relationships they have with any commercial interest(s) as well as the nature of the relationship. Financial relationships of immediate family members must also be disclosed if the nature of the relationship(s) could influence the objectivity of the individual in a position to control the content. The ACCME describes relevant financial relationships as those in any amount occurring within the past 12 months that create a conflict of interest. Individuals who refuse to disclose are disqualified from participation in the development, management, presentation, or evaluation of the CME activity.
For information regarding this educational activity or website, please contact
UAMS Office of Continuing Education
4301 W. Markham #525
Little Rock, AR 72205 Phone: 501-661-7962 Fax: 501-661-7968
