Updated: 3/10/2016

recommended literature for the CMP-HC

This list represents books, periodicals and other electronic and print resources identified by subject matter experts as offering authoritative treatment of the domains contained in the CMP-HC Standards. The recommended literature list should not be interpreted as required reading. The list directs candidates to resources they may find useful when preparing for the exam. Candidates should review the CMP-HC Standards to assess their level of knowledge in each of the three domains and develop their own reading list and study plan based on their individual needs and knowledge.

books/publications

1. Events Industry Council Manual, 9th Edition

2. MPI CMP Healthcare Training Manual http://store.publishingconceptsllc.com/shop/mpicmp-healthcaretrainingmanual/

3. Institute of Laboratory Animal Research, Commission on Life Sciences, National Research

Council, Guide for the Care and Use of Laboratory Animals http://grants.nih.gov/grants/olaw/Guide-for-the-care-and-use-of-laboratory-animals.pdf

4. Medical Meetings Magazine

http://meetingsnet.com/medical-meetings

5. Professional Convention Management, Professional Meeting Management: Comprehensive Strategies For Meetings, Conventions, and Events, Fifth Edition, Kendall Hunt Publishing Company

6. Schaumann, Pat, Breaking the Code to Healthcare Compliance, 2nd Edition, Publishing Concepts LLC, 2015

7. Pharmaceutical and Life Sciences Meetings Terms Glossary, Meetingsnet.com, Lisa

Keilty, 2015 http://meetingsnet.com/pharma-meeting-planning/pharmaceutical-and-life-sciences-meetings- terms-glossary-0

organizations/websites

Many of the websites listed below should be used by the candidate to gather information on the areas of the CMP-HC Standards for which they need clarification or examples.

8. Accreditation Council for Continuing Medical Education (ACCME)

http://www.accme.org

9. Accreditation Council for Pharmacy Education (ACPE) https://www.acpe-accredit.org/standards/default.asp

Updated: 3/10/2016

10. Advanced Medical Technology Association (AdvaMed) http://advamed.org/

Advamed Sunshine Comments http://advamed.org/res.download/299

Code of Ethics Brochure http://advamed.org/res/110/code-of-ethics-brochure Code of Ethics Best Practice http://advamed.org/res.download/395 Code of Ethics on Interactions with Health Care Professionals http://advamed.org/issues/1/code-of-ethics

11. American Academy of Family Physicians (AAFP) www.aafp.org

Guidelines for Writing Learning Objectives www.aafp.org/dam/AAFP/documents/cme/faculty_development/LearningObjectivesGuidelines.pdf

12. American Association of Tissue Banks (AATB)

Current Good Tissue Practice http://www.aatb.org/aatb/files/ccLibraryFiles/Filename/000000000642/AATBGuidanceDocument No3CGTP6-27-06.pdf

13. American Board of Internal Medicine (ABIM) http://www.abim.org/

14. American College of Foot and Ankle Surgeons (ACFAS) http://www.acfas.org/

Complying with Stark Rule: The Basics http://www.acfas.org/Physicians/content.aspx?id=647

15. American Medical Association (AMA)

http://www.ama-assn.org/ama

AMA PRA Frequently Asked Questions for CME Provide http://csms.org/wp-content/uploads/2014/03/provider-faq2.pdf

Continuing Medical Education Licensure for Reregistration http://www.ama-assn.org/ama/pub/education-careers/becoming-physician/medical- licensure/cme-licensure.page

Updated: 3/10/2016

AMA PRA Frequently Asked Questions for CME Providers http://www.ama-assn.org/resources/doc/cme/provider-faq-2012.pdf

Physician Financial Transparency Reports (Sunshine Act) http://www.ama-assn.org/ama/pub/advocacy/topics/sunshine-act-and-physician-financial- transparency-reports.page

Physician Resources for CME http://www.ama-assn.org//ama/pub/about-ama/awards/ama-physicians-recognition-award.page

State “sunshine” laws

https://www.ama-assn.org/resources/doc/washington/state-sunshine-laws-chart.pdf

The Physician's Recognition Award & Credit System http://www.ama-assn.org/resources/doc/cme/pra-booklet.pdf

Toolkit for Physician Financial Transparency Reports (Sunshine Act) http://www.ama-assn.org/ama/pub/advocacy/topics/sunshine-act-and-physician-financial- transparency-reports.page

16. American Medical Writers Association (AMWA)

http://www.amwa.org/

Physician Payment Sunshine Act: Potential Implications for Medical Publication Professionals http://www.amwa.org/Files/Publications/physicialpaymentssunshineact.pdf

17. American Osteopathic Association

http://www.osteopathic.org/

Accreditation Requirements Category 1 CME Sponsors http://www.osteopathic.org/inside-aoa/accreditation/Documents/cme-accreditation- requirements.pdf

18. American Speech-Language-Hearing Association (ASHA)

http://www.asha.org/

19. Centers for Medicare and Medicaid Services (CMS)

http://www.cms.gov/

Affordable Care Act Section 6002 Final Rule http://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment- Transparency-Program/Downloads/Final-Rule.pdf

CMS.gov Frequently Asked Questions https://questions.cms.gov/faq.php?id=5005&faqId=8165 Fact Sheet http://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment- Transparency-Program/Downloads/Applicable-Manufacturer-fact-sheet.pdf

Updated: 3/10/2016

National Physician Payment Transparency Program https://s3.amazonaws.com/public-inspection.federalregister.gov/2013-02572.pdf

Physician Self-Referral http://www.cms.gov/Medicare/Fraud-and- Abuse/PhysicianSelfReferral/index.html?redirect=/physicianselfreferral/

20. Clinical Trials

http://clinicaltrials.gov/ 21. Continuing Education and Professional Development (CEPD) University of

Toronto http://www.cepd.utoronto.ca/

Compliances for the purpose of Accreditation Request http://www.cepd.utoronto.ca/how-to-get-u-of-t-accreditation/

Needs Assessment, Goals and Objectives http://www.cepd.utoronto.ca/newsletter/2009_fall/Quick_Tips_initiating_a_learning_needs_asses ment Gap_Analysis_of_health_care_issues.pdf

22. Convention Strategy

http://www.conventionstrategy.com/

Accurately measuring attendance for session tracking, behavioral analysis and general event trends http://www.conventionstrategy.com/downloads/CS_AttendanceTracking.pdf

RFID Attendance Management http://www.conventionstrategy.com/downloads/CS_AttendanceTracking.pdf

23. Effective Meetings

http://www.effectivemeetings.com/

How to Create an Agenda http://www.effectivemeetings.com/meetingplanning/agenda/agenda.asp

24. eHow

http://www.ehow.com/

Advantages and Disadvantages of Product Life Cycles http://www.ehow.com/info_8618550_advantages-disadvantages-product-life-cycles.html

Understanding Marketing & Development http://www.ehow.com/info_8618550_advantages-disadvantages-product-life-cycles.html

25. EucoMed

http://www.eucomed.org/

Updated: 3/10/2016

27. Event Planning: A blog by Cvent

http://blog.cvent.com/

5 Best Practices of On-Line Registration Forums http://blog.cvent.com/blog/meeting-and-event-technology-best-practices/5-best-practices-of- best-online-registration-forms

28. Environmental Protection Agency (EPA)

http://www.epa.gov

State Medical Waste Programs and Regulations http://www.epa.gov/osw/nonhaz/industrial/medical/programs.htm

29. European Federation of Pharmaceutical Industries and Associations (EFPIA)

http://www.efpia.eu/topics/codes-of-practice

EFPIA Code of Ethics http://www.efpia.eu/documents/45/91/Codes-of-Practice

30. Health Care Compliance Association (HCCA)

http://www.hcca-info.org/Resources/ResourceOverview.aspx 31. Health Care Congress

http://www.healthcarecongress.net/

Accountability Issues in Healthcare Congress Management http://www.healthcarecongress.net/pdf/070117Accountability%20Issues.pdf

Safety and Security at Healthcare Congresses http://www.healthcarecongress.net/pdf/safety.pdf

32. Healthcare Convention and Exhibitors Association (HCEA)

http://www.hcea.org/

Collecting NPI Numbers http://www.hcea.org/news/112934/Collecting-NPI-Numbers-Healthcare-Assoc.-are-On-the- Frontline-for-Exhibitor-PPACA-Compliance.htm

Guidelines for Scientific Exhibits and Poster Displays: Application, Production and Presentation http://c.ymcdn.com/sites/www.hcea.org/resource/resmgr/docs/guidelines_scientific-exhibi.pdf

Guidelines for US Healthcare Conventions http://c.ymcdn.com/sites/www.hcea.org/resource/resmgr/docs/hcea_2008_guidelines.pdf

Sunshine Rules Released: Data Collection Starts August 1 https://hcea.site-ym.com/news/116169/Sunshine-Rules-Released-Data-Collection-Starts-August- 1.htm

Updated: 3/10/2016

Three Cost Categories Account for 71% of Healthcare Exhibitor Expenses http://www.hcea.org/

Top 10 Mistakes Convention Managers Make in Europe and How to Avoid Them http://www.hcea.org/?page=news_info_2011_12

33. International Association of Professional Congress Organizers (IAPCO)

http://www.iapco.org

First Steps in the Preparation of an International Medical Meeting for the Chairman of the Meeting http://www.iapco.org/pdf/firststeps_hca.pdf

Guidelines for the International Scientific Programme Committee http://www.imex- frankfurt.com/documents/GuidelinesfortheChairmanoftheScientificProgramme.pdf

34. International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)

http://www.ifpma.org/

Planning http://www.ifpma.org/fileadmin/content/Publication/2012/IFPMA_Code_of_Practice_2012_new_l ogo.pdf

Travel Criteria http://www.ifpma.org/fileadmin/content/Publication/2012/IFPMA_Code_of_Practice_2012_new_l ogo.pdf

35. International Pharmaceutical Congress Advisory Association (IPCAA)

http://www.ipcaa.org/

IPCAA Healthcare Congress Guidelines http://www.ipcaa.org/assets/IPCAA_Healthcare_Congress_Guidelines, 6th_Edition,_Jan._2012.p df

Recorded Meetings http://www.ifpma.org/fileadmin/content/Publication/2012/IFPMA_Code_of_Practice_2012_new_l ogo.pdf

36. MaRs

http://www.marsdd.com/

Product development lifecycle: New drug development http://www.marsdd.com/articles/drug-development-lifecycle/

37. Medispend

https://www.medispend.com/

Updated: 3/10/2016

38. Meeting Professionals

International http://www.mpiweb.org/Home

Business Value of Meetings: Analysis and Reporting http://www.mpiweb.org/File/219680/2032160137/bvom_whitepaper5.pdf.aspx

How-to Guide: The Strategic Value of Virtual Meetings and Events http://www.mpiweb.org/File/219680/1594226439/vm-howto.pdf.aspx

39. Meetings and Conventions

http://www.meetings-conventions.com/

Critical Challenges for Medical-Pharmaceutical Meetings http://www.meetings-conventions.com/articles/critical-challenges-for-medical-pharmaceutical- meetings/a38780.aspx

Understanding Value-Added Tax http://www.meetings-conventions.com/articles/understanding-value-added-tax/a42014.aspx

40. Meetings Focus

http://www.meetingsfocus.com/

2009 PhRMA Code Q&A http://www.meetingsfocus.com/ArticleDetails/tabid/162/ArticleID/12222/Default.aspx

E-Security Tips for Planners http://www.meetingsfocus.com/ArticleDetails/tabid/162/ArticleID/19612/Default.aspx

PhRMA Code Q&A http://www.meetingsfocus.com/ArticleDetails/tabid/162/ArticleID/12222/Default.aspx

Rules & Regs http://www.meetingsfocus.com/ArticleDetails/tabid/162/ArticleID/20449/Default.aspx

41. MeetingsNet

http://meetingsnet.com/

4 Lawsuits Just Waiting to Happen http://meetingsnet.com/risk-management/4-lawsuits-just-waiting-happen

Build Security-Related Issues Into Your Meeting Budget http://meetingsnet.com/pharma-meeting-planning/build-security-related-issues-your-meeting- budget

Copyright and CME http://meetingsnet.com/cme-design/copyright-and-cme

Ethical Hypothetical: Check Your CME Needs Assessment

Updated: 3/10/2016

http://meetingsnet.com/cme-regs/ethical-hypothetical-check-your-cme-needs-assessment

Hotel Contract Strategies for Pharma Meetings http://meetingsnet.com/negotiatingcontracts/hotel-contract-strategies-pharma-meetings

How to Negotiate Meeting Contracts http://meetingsnet.com/pharma-meeting-planning/how-negotiate-meeting-contracts?page=5

Look Who's Talking: Contracts for Speakers http://meetingsnet.com/corporatemeetingsincentives/meetings_look_whos_talking_64

Managing Life Sciences Meetings Budgets http://meetingsnet.com/pharma-meeting-planning/managing-life-sciences-meeting-budgets

Many Docs Still Clueless about Sunshine Act http://meetingsnet.com/medical-meetings/many-docs-still-clueless-about-sunshine-act?page=2

Stark Law squeezes CME http://meetingsnet.com/cmepharma/cme/phase_iii_stark_cms_012808/

State Gift Bans for HCPs http://meetingsnet.com/medicalmeetings/cme_rules_regs/0503-state-gift-bans-hcps/

Success Strategies for Digital Meetings http://meetingsnet.com/virtualhybrid/success-strategies-digital-meetings

The Risks and Rewards of Pharmaceutical Meetings http://meetingsnet.com/pharma-meeting-planning/risks-and-rewards-pharmaceutical-meetings

42. Meeting Professionals International Northern California Chapter

http://www.mpincc.org/

Contracts 2.0 - Essential Meeting Contract Clauses for 2011 & Beyond http://www.mpincc.org/assets/GRIMES_ContractsHandout_Rev%2001-31-11.pdf

43. McDermott Will & Emery

http://www.mwe.com/

IFPMA Releases Revised Code for Interactions with Health Care Professionals and Other Stakeholders http://www.mwe.com/IFPMA-Releases-Revised-Code-for-Interactions-with-Health-Care- Professionals-and-Other-Stakeholders-03-16-2012/

44. Minnesota Board of

Pharmacy http://www.phcybrd.state.mn.us/mn_home.htm

Minnesota Board of Pharmacy Payments to Practitioners Documents http://www.phcybrd.state.mn.us/main_pay.htm

Updated: 3/10/2016

45. National Council of Nonprofits www.councilofnonprofits.org

46. Nurse Credentialing

http://www.nursecredentialing.org/

2013 Certification Renewal Requirements http://www.nursecredentialing.org/RenewalRequirements.aspx

47. Office of Inspector General U.S. Department of Health & Human Services

www.oig.hhs.gov 48. Occupational Safety and Health Administration (OSHA)

https://www.osha.gov/

Corporate Integrity Agreements https://oig.hhs.gov/compliance/corporate-integrity-agreements/index.asp

HIPAA Privacy, Security, and Breach Notification Audit Program http://www.hhs.gov/ocr/privacy/hipaa/enforcement/audit/index.html

Training Requirements in OSHA Standards and Training Guidelines http://www.osha.gov/Publications/2254.html

49. Pharmaceutical Research and Manufacturers of America (PhRMA)

http://www.phrma.org/

Code on interactions with Healthcare Professionals http://www.phrma.org/sites/default/files/pdf/phrma_marketing_code_2008.pdf

Principles of Conduct of Clinical Trials http://phrma.org/sites/default/files/pdf/042009_clinical_trial_principles_final_0.pdf

50. Policy and Medicine

http://www.policymed.com/

FDA: Off-Label May Be the Wrong Label http://www.policymed.com/2010/05/fda-off-label-may-be-the-wrong-label.html

National Physician Payment Transparency Program: OPEN PAYMENTS (Section 6002 of the Affordable Care Act) http://www.policymed.com/physician-payment-sunshine-act/

Physician Payment Sunshine Act http://www.policymed.com/2013/02/physician-payment-sunshine-act-final-rule-definitions.html

Updated: 3/10/2016

Physician Payment Sunshine Act: Final Rule Top 50 Things to Know http://www.policymed.com/2013/02/physician-payment-sunshine-act-top-50-things-to-know.html

51. PubMed

http://www.ncbi.nlm.nih.gov/pubmed

New federal guidelines for physician-pharmaceutical industry relations: The politics of policy formation http://www.ncbi.nlm.nih.gov/pubmed/16136634

52. Royal College of Physicians and Surgeons of Canada

http://www.royalcollege.ca/

A steady evolution toward competency-based medical education http://www.royalcollege.ca/portal/page/portal/rc/resources/cbme

Accreditation http://www.royalcollege.ca/portal/page/portal/rc/members/cpd/cpd_accreditation/group_learnin g/cpd_accreditation_toolkit/accreditation_faq

Agenda Goals http://www.royalcollege.ca/portal/page/portal/rc/members/cpd/cpd_accreditation/group_learnin g/cpd_accreditation_toolkit/accreditation_faq

Tagging http://www.royalcollege.ca/portal/page/portal/rc/members/cpd/cpd_accreditation/group_learnin g/cpd_accreditation_toolkit/accreditation_faq

53. The Royal College of Surgeons of England

http://www.rcseng.ac.uk/ 54. Slideshare

http://www.slideshare.net/

Overview of Drug Development and Clinical Trials http://www.slideshare.net/rajsadare/drug-development-life-cycle

55. Successful Meetings

http://www.successfulmeetings.com/

Secure Lines: Protecting Your Meeting Content http://www.successfulmeetings.com/Event-Planning/conference-management/Articles/Secure- Lines--Protecting-Your-Meeting-Content/

The Sunshine Act Casts a Long Shadow http://www.successfulmeetings.com/Event-Planning/Conferences/Articles/The-Sunshine-Act- Casts-a-Long-Shadow/

Updated: 3/10/2016

56. System Dynamics Case Repository http://cases.systemdynamics.org/

Pharmaceutical Product Life Cycles http://cases.systemdynamics.org/?p=39

57. The Accreditation of Canadian University CME/CPD Offices

http://www.afmc.ca/

Accreditation Standards http://www.afmc.ca/pdf/FINAL_CACME_Standards_2010_ENGLISH.pdf

58. University of Michigan Occupational Safety & Environmental Health

http://www.oseh.umich.edu/

Radiation Monitoring Dosimeters Information Sheet http://www.oseh.umich.edu/radiation/RadMonitorDosimeters.shtml

59. University of Toronto Surgical Skills Centre at Mount Sinai Hospital

http://www.utoronto.ca/ssc/index.html 60. U.S. Department of Health & Human Services

http://www.hhs.gov/

Department of Health & Human Services 42 CFR Parts 402 and 403 https://s3.amazonaws.com/public-inspection.federalregister.gov/2013-02572.pdf

HIPAA Privacy, Security, and Breach Notification Audit Program http://www.hhs.gov/ocr/privacy/hipaa/enforcement/audit/index.html

61. U.S. Food and Drug Administration (FDA)

http://www.fda.gov/

Basic Questions and Answers about Clinical Trials http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm1 21345.htm

Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information about Prescription Drugs and Medical Devices http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UC M285145.pdf

The FDA’s Drug Review Process: Ensuring Drugs are Safe and Effective http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm

Updated: 3/10/2016

62. U.S. Securities and Exchange Commission http://www.sec.gov/

Securities and Exchange Commission - Sarbanes Oxley http://www.sec.gov/about/laws/soa2002.pdf

63. Wikipedia

http://en.wikipedia.org/

Data Management Plan http://en.wikipedia.org/wiki/Data_management_plan