Developer: Dana Shaw-Bailey, M.Ed.
Contributors: Darri Scalzo; Candi Langmaid; Kurtis Kulbeth, BS; Carol Sikes, RN, MScN; Phyllis Nader, BSE
Knowledge Gap:
The purpose of this activity is to educate healthcare providers with the most up-to-date information on common clinical trials audit finding and addressing those findings.
Target Audience:
The target audience includes all healthcare professionals such as physicians, nurses, pharmacists and allied health professionals who would like to learn about best practices when facing a clinical trial audit.
Program Overview:
The purpose of this activity is to educate medical professionals on the approaches and best practices when faced with a clinical trial audit.
Release and Expiration Dates
08/05/2020 – 08/05/2023
Objectives:
Explain the purpose and scope of an audit.
Define the two conditions for audits.
List the common compliance areas reviewed during an audit.
References:
Modules: Introduction and Preparing for a Site Audit
https://www.advarra.com/resource-library/preparing-for-and-responding-to-an-fda-inspection/
https://nccih.nih.gov/sites/nccam.nih.gov/files/cr-toolbox/regulatory_binder_checklist_ver3_07-17-2015.docx
https://mtnstopshiv.org/sites/default/files/attachments/Site_FDA_Inspection_Preparation_Checklist_v1[1].0_22Nov10.doc
Module: Participating in a Site Audit
https://oprs.usc.edu/files/2017/05/FDA-SHEDDING-LIGHT-PRESENT-for-USC-Oct-2016.pptx
https://nbscience.files.wordpress.com/2014/12/audit2.ppt
https://www.fdanews.com/ext/resources/files/The_Food_And_Drug_Letter/2013/Inspection-Readiness-ExecSeries.pdf
http://www.med.upenn.edu/ocrobjects/library/HowtoSurviveFDA_Audit.pdf
https://www.advarra.com/resource-library/preparing-for-and-responding-to-an-fda-inspection/
Module: Addressing the Findings
https://research.unc.edu/files/2018/02/2.7.18-ctqa-common-findings-presentation.pdf
http://compliance.emory.edu/documents/AuditFindingsinClinicalTrials.pdf
https://www.fda.gov/media/87613/download
Raju S, Vijaya Lakshmi N, Sathish M. Audit of an investigator site – a crucial task in clinical research to ensure a reliable clinical trial: review of planning, methodology and techniques. International Journal of Research and Development in Pharmacy and Life Sciences 2016;5(4):13-29.
Narrator: Kristina Foster, MS, RN
Planners: Jessica Snowden, MD; Jeanette Lee, Ph.D., Lora Lawrence, RN; Catrice Banks-Johnson, MPA; DeAnn Hubberd, MA; Dana Shaw-Bailey, M.Ed.
Peer Review: Megan Bledsoe, PhDc, MSc; Kristina Foster, RN, MS, APRN-BC
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
