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Practical Resources for Clinical Research Professionals

Interested in some useful new resources to better conduct research? Please watch and share my new prezi!
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Christina Philyaw

on 16 July 2013

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Transcript of Practical Resources for Clinical Research Professionals

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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
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The objective of this presentation is to provide RAs, CRCs, and CRAs with resources to meet those needs
Context:
Introduction
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First CAREER!!!
@ Capgemini
:)
Jacob B-day!
Get present
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
Essentials...
Supplementary Resources
Continuing Education
Forums:
Educational Programs
Website:
http://www.coapcr.org/membership/membership-directory/
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
Medical History
Sam Hall
4354 Streetname Ln.
23205 Norfolk, VA
Christy Philyaw
620 John Paul Jones Circle
Portsmouth, VA 23708
Dear Sam,
Thank you so much for participating in our research study. You have made a great impact in pharmaceutical research. Thank you for your time!
Best,
Christy
TO DO:
FedEx Labs
Follow up w/ S043
Study visit for R19
Complete Reg Docs
Contact CRA

References
Objective
Essential Resources
Reference Manuals
Trainings
Guidelines
International
National
Local
by Stephen B. Hulley, Steven R. Cummings, Warren S. Browner, Deborah G. Grady, Thomas B. Newman
Monthly Prescribing Reference (MPR)
ICH Applicable Guidelines

Website: (http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html)
Website: Search for state-specific statutes online
by Karen E. Woodin, Ph.D.
http://phrp.nihtraining.com/users/login.php
http://ohrp-ed.od.nih.gov/CBTs/Assurance/login.asp
Publications
The Monitor by The Association of Clinical Research Professionals (ACRP)
(http://www.socra.org/html/newslett.htm)
http://www.raps.org/focus-online.aspx
(http://www.diahome.org/en-US/News-and-Publications.aspx)
(http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/issue/issueDetail.jsp?id=22967)
PharmaVOICE (http://www.pharmavoice.com/content/index.html?)
(http://www.firstclinical.com/journal/contents.html)
Clinical Research
News
DIA News
CenterWatch News Online
Recruitment & Retention
Newsletters
Prezi
Skype
iMovie
Webmatrix
Study Visits
Website: PubMed http://www.ncbi.nlm.nih.gov/pubmed/
App: New England Journal of Medicine App
ConMeds
Websites
Apps
Medline
Epocrates
WebMD
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
Texts
Safety alerts delivered via SMS to your cell/smart phone. Choose “Wireless Alerts” option in the MedWatch E-list signup.
Twitter: http://twitter.com/FDAMedWatch
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: www.fda.gov
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
Additional Organizations

- NIH: http://nih.gov/
Bioethics Resources on the Web:
www.nih.gov/sigs/bioethics/IRBs/html

- 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
http://www.srainternational.org/sra03/index.cfm
Conclusion
- 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
2. MPR
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
TRAINING OPPORTUNITIES
SoCRA 22nd Annual Conference
Faces of Global Research: Compliance, Quality, Integrity and Human Subjects Protection
New Orleans, Louisiana - September 27, 28, and 29, 2013
Website (http://www.ich.org)
Declaration of Helsinki
Website (http://www.wma.net/en/30publications/10policies/b3/)
E2A, E6, E8, E9
1.21 U.S. Code of Federal Regulations: Parts 11, 50, 56, 312, 812
Website: (http://www.fda.gov)
45 U.S. Code of Federal Regulations: Part 46
Department of Health and Human Services (HHS) Protection of Human Subjects Regulations. 45 CFR 46:
Website: (http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm)
Nuremberg Code
Website: (http://www.hhs.gov/ohrp/archive/nurcode.html)
Belmont Report
State Statutes
Site-Specific SOPs
CITI Training
Webbsite: (https://www.citiprogram.org/Default.asp?)
The Consortium of Academic Programs in Clinical Research Brief List:
Applied Clinical Trials’ Thorough List of Educational Courses/ Programs/ Degrees Available:
Website: (http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/article/articleDetail.jsp?id=392462&pageID=1&sk=&date=)
Recruitment
&
Retention
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://216.30.191.162/Monitor/
2007September/duane.pdf.

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,
1123-1130.

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.
(Norris, 2009)
(Norris, 2009)
(Norris, 2009)
(Woodin, 2011)
(Norris, 2009)
(Norris, 2009)
(Norris, 2009)
(Norris, 2009)
OHRP Human Subjects Assurance Training:
NIH Protecting Human Research Participants
Designing Clinical Research
The CRCs Guide to Coordinating Clinical Research
(http://www.acrpnet.org/MainMenuCategory/Resources/TheMonitor.aspx)
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
(Norris, 2009)
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!
Submit Timesheet!
Ask your site manager for site-specific Standard Operating Practices (SOPs)
(http://www.diahome.org/en-US/News-and-Publications.aspx)
(http://www.centerwatch.com/news-online/)
Certified Clinical Research Coordinator (CCRC)
Certified Clinical Research Associate (CCRA)
Certified Principal Investigator (CPI)
Certified Clinical Research Professional (CCRP)
Regulatory Affairs Certification (RAC)
Certifications
Association of Clinical Research Professionals (ACRP)
Society of Clinical
Research Associates
(SoCRA)
Regulatory Affairs Professionals Society (RAPS)
- Pages for Macs
- Publisher for PCs
http://prezi.com
http://skypeforfree.com/go/skype?subid=skype&source=bing_skype-search-us-3
http://windows.microsoft.com/en-US/windows-live/movie-maker-get-started
Microsoft Movie Maker
http://www.apple.com/ilife/imovie/
http://www.microsoft.com/web/webmatrix/
Full transcript