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Practical Resources for Clinical Research Professionals
Transcript of Practical Resources for Clinical Research Professionals
Lunch w/ Kelly
Clearly, RAs, CRCs, and CRAs could benefit from resources that allow for greater clinical research efficiency, accuracy, and education
by Christy Philyaw, BS, CCRC, CCRP
Practical Resources for Clinical Research Professionals
The objective of this presentation is to provide RAs, CRCs, and CRAs with resources to meet those needs
Approximately 75% of Clinical Research Coordinators surveyed have received no formal coordinator training (Duane et al., 2007)
About 44% of Clinical Research Coordinators surveyed report high emotional exhaustion, a component of burnout (Gwede et al., 2005)
While 53% of Clinical Research Coordinators surveyed reported that 4-6 studies were considered a reasonable workload, 51% of Clinical Research Coordinators reported workloads that exceeded 7+ studies! (Duane et al., 2007)
The following resources were compiled from lectures at clinical research educational training sessions, reference manuals, websites, as well as solicited responses from online forums consisting of clinical research professionals
All resources discussed are free and/or readily available at your local library
Resources based on Standard CRC Tasks
1. ACRP (http://www.acrpnet.org/
2. Accrualnet on the NCI website (https://accrualnet.cancer.gov
3. First Clinical Research (http://firstclinical.com/fda-gcp/)
4. Clinical Research Society (http://www.clinicalresearchsociety.org/forum/index.php)
Books & DVDs
NIH Templates (http://www.nidcr.nih.gov/Research/toolkit/)
Checklists & Templates for Protocols, ICFs, Source Docs, CRFs, and Logs
4354 Streetname Ln.
23205 Norfolk, VA
620 John Paul Jones Circle
Portsmouth, VA 23708
Thank you so much for participating in our research study. You have made a great impact in pharmaceutical research. Thank you for your time!
Follow up w/ S043
Study visit for R19
Complete Reg Docs
by Stephen B. Hulley, Steven R. Cummings, Warren S. Browner, Deborah G. Grady, Thomas B. Newman
Monthly Prescribing Reference (MPR)
ICH Applicable Guidelines
Website: Search for state-specific statutes online
by Karen E. Woodin, Ph.D.
The Monitor by The Association of Clinical Research Professionals (ACRP)
CenterWatch News Online
Recruitment & Retention
Website: PubMed http://www.ncbi.nlm.nih.gov/pubmed/
App: New England Journal of Medicine App
FDA Drug Information Index: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111085.htm
NIH Daily Med: http://dailymed.nlm.nih.gov/dailymed/about.cfmDrugs.com: http://www.drugs.com/iv.rxlist.com: http://www.rxlist.com/script/main/hp.aspv.
Merck Manual: http://www.merckmanuals.com/professional/index.html
NIH Medline (resources for complementary and alternative medicine): http://www.nlm.nih.gov/medlineplus/
Serious Adverse Events Reporting
Safety alerts delivered via SMS to your cell/smart phone. Choose “Wireless Alerts” option in the MedWatch E-list signup.
FDA Information Sheets: www.fda.gov/oc/ohrt/irbs/default.htm- represent the agency's current thinking on protection of human subjects in research
FDA forms: http://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/default.htm
Audit Preparation and/or Attendance
FDA Warning Letters (http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm)
You can sign up to receive notifications when the most recently posted warning letters are available for the public
- NIH: http://nih.gov/
Bioethics Resources on the Web:
- Public Responsibility in Medicine and Research (http://www.primr.org/)
- The Foundation Center (http://www.foundationcenter.org/)
Center maintains a searchable database of foundations, their websites, and contact information, along with advice about how to obtain grants and write effective proposals to foundations
- Regulatory Affairs Professionals: http://www.raps.org/
- Society of Quality Assurance Professionals (http://www.sqa.org/rqap/)
- Society of Research Administrators
- By using some of these resources, you have the opportunity to increase your clinical research efficiency, accuracy, and knowledge
- All resources in this presentation include applicable website links should you wish to review this presentation in the future
- What resources do you use?
- Additional thoughts or questions?
1. The CRA’s Guide to Coordinating Clinical Research
3. Tarascon Pocket Pharmacopoeia
4. Bad blood The Tuskegee Syphilis Experiment
5. Acres of Skin
6. Code of Medical Ethics
7. Factories of Death
8. Guide to Clinical Trials
9. Advisory Committee on Human Radiation Experiments
10. The Nazi Doctors
11. The Placebo Effect
12. Protecting Study Research Volunteers
13. Tuskegee’s Truths
14. The Immortal Life of Henrietta Lacks
15. A Simple Guide to SPSS for Windows
SoCRA 22nd Annual Conference
Faces of Global Research: Compliance, Quality, Integrity and Human Subjects Protection
New Orleans, Louisiana - September 27, 28, and 29, 2013
Declaration of Helsinki
E2A, E6, E8, E9
1.21 U.S. Code of Federal Regulations: Parts 11, 50, 56, 312, 812
45 U.S. Code of Federal Regulations: Part 46
Department of Health and Human Services (HHS) Protection of Human Subjects Regulations. 45 CFR 46:
The Consortium of Academic Programs in Clinical Research Brief List:
Applied Clinical Trials’ Thorough List of Educational Courses/ Programs/ Degrees Available:
Duane C. G., Granda, S. E., Munz D.C., Cannon J. C.
(2007). Study coordinators' perceptions of their
work experiences. The Monitor (September), 39-42.
Available from http://220.127.116.11/Monitor/
Gwede C. K., Johnson D. J., Roberts C, & Cantor, A. B.,
(2005). Burnout in clinical research coordinators in
the United States. Oncology Nursing Forum, 32, 6,
Norris, D. (2009). Clinical research coordinator handbook.
Medford, NJ: Plexus Publishing, Inc.
Woodin K. E. (2011) The CRC's guide to coordinating
clinical research. Boston, MA: CenterWatch.
OHRP Human Subjects Assurance Training:
NIH Protecting Human Research Participants
Designing Clinical Research
The CRCs Guide to Coordinating Clinical Research
The Source by the Society of Clinical Research Associates (SoCRA)
Regulatory Focus by Regulatory Affairs Professional Society
Drug Information Association Publications
Applied Clinical Trials Journal
Journal of Clinical Research Best Practices
Up-To-Date: Some medical facilities have access to this very expensive program that you can use to search for excellent information regarding diagnoses and medications. http://www.uptodate.com/contents/search
It is located near the top left of the library home page. Search for what what you need and click on summary (green box on left) for a concise general understanding of the article/subject.
When is the next Ethics Roundtable Meeting?
Ask for help with Concur!
Ask your site manager for site-specific Standard Operating Practices (SOPs)
Certified Clinical Research Coordinator (CCRC)
Certified Clinical Research Associate (CCRA)
Certified Principal Investigator (CPI)
Certified Clinical Research Professional (CCRP)
Regulatory Affairs Certification (RAC)
Association of Clinical Research Professionals (ACRP)
Society of Clinical
Regulatory Affairs Professionals Society (RAPS)
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