N AT I O N A L B O A R D O F M E D I C A L E X A M I N E R S ®

C E R T I F I C A T I O N E X A M I N A T I O N S

IMPROVING HEALTHCARE AROUND

THE WORLD THROUGH ASSESSMENT

2016BULLETIN OF INFORMATION

COMMUNICATING WITH THE NBME CLINICAL RESEARCH PROGRAM 3 General Information, Application, and Registration Inquiries 3 Test Day Inquiries 3 Eligibility or Pass/Fail Decision Inquiries 3

ABOUT NBME’S CLINICAL RESEARCH PROGRAM CERTIFICATION 4 Purpose 4 Clinical Research Program Examination Description 5 Content Categories 6 Registration 6

ELIGIBILITY 7 Who can take the Monitor, Associate, and Coordinator Certification Exam? 7 Who can take the Investigator and Scientist Certification Exam? 8 Eligibility Window 9 Eligibility Verification 9 Accepted Academic Institution Criteria 10 Change in Eligibility Status 10 Policy on Retaking the Examinations 10

APPLYING FOR THE TEST AND SCHEDULING YOUR TEST DATE 11 Application Materials 11 Examinees Requesting Test Accommodations 11 Personal Item Exceptions 11

TEST ACCOMMODATIONS 14

EXAMINATION DAY AND TESTING 15 Testing Regulations and Rules of Conduct 15 Personal Belongings in the Testing Room 16 Admission to the Test 17 Break Time 18 Starting and Completing the Test 19 Cancelling or Rescheduling Your Exam 19

SCORING AND SCORE REPORTING 20 Score Reporting 20 Score Verification 20 Score Validity 21 Anomalous Performance 21

SECURITY & INTEGRITY OF THE CRP EXAMINATIONS 22 Examinee Responsibilities 22 Web-based Examination Administrations at Your Institution 22 Contacting NBME about a Security Concern 22

EXAMINATION CONTENT OUTLINES 23

SAMPLE CLINICAL RESEARCH PROGRAM EXAM ITEMS 25

SAMPLE SCORE REPORT AND INTERPRETATION GUIDE 29

SAMPLE EXAMINEE ELIGIBILITY COVERSHEET 32

TABLE OF CONTENTS Page #

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Copyright © 2016 National Board of Medical Examiners® (NBME®). All rights reserved.

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IMPORTANT How to use the CRP Bulletin of Information

CRP requires that all applicants read this entire bulletin. The purpose of this bulletin is to provide you with important information about the policies and procedures for obtaining the CRP

Certification.

COMMUNICATING WITH THE NBME CLINICAL RESEARCH PROGRAM

GENERAL INFORMATION, APPLICATION, AND REGISTRATION INQUIRIES For information on how to apply for the Clinical Research Program (CRP) examinations, obtain application materials, and receive information on the status of your application, appeal eligibility or pass/fail decision, contact:

Attention: CRP Registration National Board of Medical Examiners 3750 Market Street Philadelphia, PA 19104-3102 Telephone: 215-495-6000 E-mail: support@nbme.org CRP Website

TEST DAY INQUIRIES For questions and concerns about your exam day, contact the NBME Test Administration office:

Attention: Test Administration Services National Board of Medical Examiners 3750 Market Street Philadelphia, PA 19104-3102 E-mail: crptestadmin@nbme.org

ELIGIBILITY OR PASS/FAIL DECISION INQUIRIES For questions and appeals regarding eligibility decisions or exam pass/fail decisions, contact:

Attention: AP – Clinical Research Program National Board of Medical Examiners 3750 Market Street Philadelphia, PA 19104-3102 E-mail: crp@nbme.org

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ABOUT NBME’S CLINICAL RESEARCH PROGRAM CERTIFICATION

PURPOSE As the nationally recognized leader in producing unbiased and reliable examinations that demonstrate evidence of validity for the health professions, the National Board of Medical Examiners (NBME) is uniquely positioned to provide a high-quality assessment in collaboration with nationally recognized subject matter experts in the field of clinical research.

NBME’s Clinical Research Program (CRP) was established to aid personnel in the field of clinical research by providing a globally recognized, high-quality certification program. The examinations are designed to provide a baseline for a universally recognized, unbiased measure of the foundational knowledge of clinical research professionals to perform safe, effective research in human subjects.

The CRP offers two certification examinations for responsibility-defined roles in the conduct of research:

Monitor, Associate, and Coordinator Certification Examination

Investigator and Scientist Certification Examination

The examinations are differentiated by the responsibilities and knowledge covered within each assessment and are designed to identify strengths and weaknesses in clinical research professionals’ knowledge. A more detailed description of the responsibilities associated with each exam can be found in the Eligibility section.

Certification will be granted in recognition of documented and verified work experience, education, and successful performance on the Monitor, Associate, and Coordinator Certification Exam or Investigator and Scientist Certification Exam. Professionals who wish to obtain certification must provide evidence of experience in specific responsibilities in the conduct of research. Evidence of education must also be demonstrated. Details of these requirements are outlined in the Eligibility section.

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CRP examinations document evidence of achieving a minimum level of knowledge required to conduct safe, effective, and efficient research. This minimum level is established in part on the findings of a Content-Based Standard Setting Study conducted by NBME with a panel of experts in the field of clinical research. These requirements are based on recognized international standards for professionals in the clinical research field. The Clinical Research Program certifications are valid for a period of four years, at which point recertification is offered.

The CRP certification is designed to ensure that all certification holders have demonstrated their competence through fair and credible measures. Steps are taken to ensure only the most reliable testing measures are used in the assessment of candidates, including:

1. Test content in the certification exam is developed by experts in clinical research.

2. All content is subject to rigorous review by subject matter experts for content and clarity.

3. Exam materials are evaluated separately by psychometricians (assessment specialists), using well-documented, best practice statistical procedures to ensure the quality of test results.

4. A final content expert review is then performed.

Candidates who meet the eligibility requirements and pass the exam will be sent an official Certificate and Maintenance of Certification information for the particular exam. Candidates who do not pass the exam are advised to review the content area scores and use this information as guidance for future self-development. Candidates who pass the exam are added to the public NBME CRP Certification Registry unless they opt out.

CLINICAL RESEARCH PROGRAM EXAMINATION DESCRIPTION Each certification examination is a web-based, computer exam that is four (4) hours and fifteen (15) minutes in length.

The 4 hour and 15 minute test session for each examination will consist of the following:

15-minute tutorial

5 blocks, 45 minutes each, of questions in multiple choice format

15 minute break between test blocks 3 and 4

Post-test survey

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CONTENT CATEGORIES The following topics are included in the assessments:

ETHICS

REGULATIONS & GUIDANCE

STUDY DESIGN & STATISTICS

SAFETY

DATA MANAGEMENT

Please see the Content Outline section for more detailed information about the content outline for each exam.

Scores will be provided to individual examinees. Organizations will receive aggregate data reports. Please see Sample Score Reports and Interpretation Guide section for score report examples.

REGISTRATION

See your organization’s contact for registration details.

The window for submitting applications for both exams is March 18, 2016 - April 15, 2016.

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ELIGIBILITY To be eligible for a CRP certification exam, professionals must meet eligibility requirements demonstrating education and experience in the field.

There are two examinations within the Clinical Research Program, each of which is designed to assess specific responsibilities and knowledge across the major content domains.

MONITOR, ASSOCIATE, AND COORDINATOR CERTIFICATION EXAMINATION Professionals eligible for the Monitor, Associate, and Coordinator Certification are responsible for:

Overseeing the progress and conduct of a trial at a site or sites

Assessing and ensuring site feasibility and qualifications of site personnel

Providing regulatory guidance and oversight

Promoting and ensuring protocol compliance

Ensuring that adverse events are identified, collected, and reported appropriately

Ensuring that data are collected, recorded, and safeguarded correctly

Managing the control of investigational products

These responsibilities are usually within the job descriptions of clinical research associates (sponsor-designated study monitors), clinical research coordinators, or clinical research managers.

WHO CAN TAKE THE MONITOR, ASSOCIATE, AND COORDINATOR CERTIFICATION EXAM? Candidates must meet both of the following eligibility requirements:

Eligibility Requirement Documentation

Education Currently enrolled in or graduate of an Associate’s, Bachelor’s, Master’s, or Doctoral program at an academic institution or completion of LPN/LVN, CMA, or MLT program or higher that meets NBME pre-defined criteria (see page 10)

Diploma, certificate or unofficial transcript in English.

Experience Held Two years’ or two trials experience with at least 3 of the responsibilities listed on page 7 over the past 7 years

CV/resume AND Letter from program or employer verifying that you have held at least 3 of the responsibilities listed on page 7 in 2 of the last 7 years.

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INVESTIGATOR AND SCIENTIST CERTIFICATION EXAMINATION Professionals eligible for the Investigator and Scientist Certification include scientists, physicians-in-training, and physicians involved in research in their practices, institutions, or Contract Research Organization (CRO)/Sponsor employers. These individuals are responsible for:

Performing study-related procedures and/or making study-related decisions as a site sub-investigator, site investigator, or a principal investigator

Ensuring the ethical conduct of the research as the investigator in a study

Overseeing a clinical research study as a principal investigator to ensure protection of humansubjects’ rights, safety, and welfare; compliance with the protocol; and adherence to institutional,state, and federal regulations

Providing medical oversight in a study as a medical monitor

Leading or assisting a project team with design, operational feasibility, and conduct of clinicalstudies

Contributing to the authorship of clinical and regulatory documents and publications

Planning, developing, and writing clinical research protocols in both sponsored and investigator-initiated settings

WHO CAN TAKE THE INVESTIGATOR AND SCIENTIST CERTIFICATION EXAM? Candidates must meet both of the following eligibility requirements:

Eligibility Requirement Documentation

Education Currently enrolled in or graduate of a Master’s or Doctoral degree program in medicine, science, at an academic institution meeting NBME pre-defined criteria (see page 10)

Diploma or unofficial transcript in English.

Experience Two years’ or two trials experience with at least 3 of the responsibilities listed on page 8 over the past 7 years

CV/resume AND one of the two documents below: 1. Letter from Employer verifying that

candidate has held at least 3 of theresponsibilities listed on page 8 in 2of the last 7 years.

OR IRB/IEB approval letter containing candidate’s name—one letter each for at least 2 of the last 7 years.

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Candidates for both exams must determine if they are eligible to sit for the examination and provide eligibility documentation as described above for the NBME to review. All documentation must be submitted together with the eligibility cover sheet (see page 31 or the CRP webpage for an example). The NBME reserves the right to independently verify credentials.

During the application process, you will be required to attest to the accuracy of the information provided as part of the application process and agree to be bound by the terms and conditions of the Bulletin of Information (BOI). By submitting an application form and eligibility documents, you consent to allow the NBME to verify your academic and employment records.

ELIGIBILITY WINDOW Once NBME verifies your eligibility, you will have a 12-month window in which to sit for the examination. Currently, you may only schedule your exam on the dates offered by your sponsoring organization. If you do not test within your 12-month eligibility window, you will need to reapply and pay a new fee.

ELIGIBILITY VERIFICATION You will supply information required for verification of eligibility:

Eligibility Cover Sheet

Copies of your credential documents for both the education and experience requirements in English,that include the information listed on the eligibility cover sheet

If you are unable to send documents by e-mail, send them through a trackable courier service to the address below. Please send all documents at one time, in one envelope. Mailing documents separately can cause delay in the review time frame. All documents should include your Candidate ID#. (A Candidate ID# will be assigned to you when you apply for the CRP Examinations.)

You will be notified by e-mail regarding the outcome of your eligibility review within 15 business days.

Address to send eligibility documents:

NBME Attn: CRP Support 3750 Market Street Philadelphia, PA 19104-3102

Please submit the requested documentation to support@nbme.org.

All eligibility documentation must be submitted by May 6, 2016.

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ACCEPTED ACADEMIC INSTITUTION CRITERIA a student officially enrolled in, or a graduate of, a school that is accredited by the Council on Higher

Education Accreditation

a medical student officially enrolled in, or a graduate of, a US or Canadian medical school programleading to the MD degree that is accredited by the Liaison Committee on Medical Education (LCME)

a medical student officially enrolled in, or a graduate of, a US medical school leading to the DOdegree that is accredited by the American Osteopathic Association (AOA), or

a medical student officially enrolled in, or a graduate of, a medical school that is outside the US andCanada, listed in the World Directory of Medical Schools, International Medical Education Directory

CHANGE IN ELIGIBILITY STATUS If your eligibility for a certification exam changes after you submit your application but before your scheduled test date(s), you must notify CRP by e-mail at support@nbme.org. If you take a certification exam for which you are not eligible, results for that examination may not be reported or, if previously reported, may be cancelled.

POLICY ON RETAKING THE EXAMINATIONS In the event that you do not pass the examination, you may retake it a maximum of two times in a 12-month period. The NBME will permit a maximum of six attempts at the examination, including incomplete attempts. All attempts at a CRP examination are counted toward the limit, regardless of when the examinations were taken. For each attempt you will need to reapply and pay the full application fee.

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APPLYING FOR THE TEST AND SCHEDULING YOUR TEST DATE

APPLICATION MATERIALS Before applying for a CRP certification exam, candidates will make sure they meet the eligibility requirements listed in the Eligibility section of the BOI. Please see the steps below for the application process:

1. You will receive an e-mail from either your sponsoring organization or the NBME with a link andinstructions on how to access the registration portal to apply for an exam.

2. You must access the registration portal, complete the required online application, and submit theinformation. The name you register under must exactly match the name listed on your governmentidentification that you will present on the day of your exam.

3. Upon submission of the application form, you will receive an e-mail with instructions on how to submityour eligibility documents. All candidates are required to submit documents to support their eligibility.

4. You must submit your complete eligibility package which includes the Eligibility Coversheet andsupporting documents to the NBME.

5. You will be notified by email within 15 business days if you meet the eligibility requirements for theexam for which you have applied.

EXAMINEES REQUESTING TEST ACCOMMODATIONS CRP provides reasonable accommodations for examinees with disabilities covered under the Americans with Disabilities Act (ADA). If you wish to apply for test accommodations, please see the Test Accommodations section of the BOI and the CRP webpage for more information.

PERSONAL ITEM EXCEPTIONS Unauthorized possession of personal items while you are in the secure areas of the testing room is prohibited. Exceptions to this policy may be made in certain limited circumstances. The personal items listed below are permitted in the testing area subject to inspection by the test site proctor. If you have a medical need for one or more of these items during your CRP examination, you do NOT need to make a request or submit documentation to NBME for approval. Please show the item to the test site proctor when you check in for your examination.

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MEDICINE AND MEDICAL DEVICES Arm/shoulder sling

Bandages

Braces – neck, back, wrist, leg, or ankle

Casts/cervical collar

Cough drops (must be unwrapped and not in a bottle/container)

Earplugs (foam with no strings)

Epi-Pen

Eye drops

Eye patches

Eyeglasses (without the case)

Glucose monitor

Glucose tablets

Handheld magnifying glass (non-electric, no case)

Ice packs/heating pads

Inhaler

Medical alert bracelet

Nitroglycerin tablets

Pillow/lumbar support

Pills (must be unwrapped and not in a bottle/container)

Stool for elevating a limb

Surgical face mask

Walking boot casts

MEDICAL DEVICE ATTACHED TO A PERSON’S BODY Catheter

Colostomy bag

Heart rate monitor

Insulin pump

Oxygen tank

Spinal cord stimulator

TENS units

Urine drainage bag

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COMMUNICATION AIDS Hearing aid/cochlear implant without Bluetooth/wireless capability

Vocal cord magnifiers

MOBILITY DEVICES Cane

Crutches

Walker

Wheelchair

If you have a medical condition that requires use of an item NOT on the above list, follow the directions for requesting a test accommodation.

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TEST ACCOMMODATIONS The Clinical Research Program provides reasonable and appropriate accommodations in accordance with the amended Americans with Disabilities Act (ADA) for individuals with documented disabilities who demonstrate a need for accommodation.

You may request the administration of any CRP examination to be modified due to disability, handicap, and/or other conditions that may impair your ability to take the examination. There are no additional costs for special accommodations.

Test accommodations include but are not limited to the following: Extended testing time

Enlarged text and graphics

Permission for assistive devices

Initiate the request for accommodations process as soon as you complete your exam registration by submitting a signed Request for Test Accommodations form and supporting documentation to the address listed on the form. Requests cannot be considered without supporting documentation. You will not be able to schedule an examination appointment until your request and supporting documentation have been reviewed and you receive a decision regarding your request. Please see the CRP webpage for additional information about the request process.

Test accommodations may not be added to a previously scheduled examination appointment. If you scheduled a standard examination and wish to request test accommodations, you must cancel your appointment and reregister prior to requesting the accommodations. There are no exceptions to this policy.

All documentation submitted in support of a request for accommodations is confidential. No information concerning a request for accommodations is released without a written request from the examinee.

While presumably the use of accommodations in the test activity will enable the individual to better demonstrate his/her knowledge mastery, accommodations are not a guarantee of improved performance, test completion, or a passing score.

Candidates are encouraged to submit requests for accommodations and supporting documentation as soon as possible and no later than the registration deadline of April 15 if you plan to test during the June

administration.

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EXAMINATION DAY AND TESTING

TESTING REGULATIONS AND RULES OF CONDUCT The administration of CRP examinations are monitored by test site proctors. Proctors are required to report any violations of test administration rules. You must follow instructions from test site proctors throughout the testing session. Test site proctors are not authorized to answer questions regarding registration, examination content or format, testing software, scoring, or retesting.

RULES OF CONDUCT When you apply to take the CRP Certification exams, you are agreeing to the following:

1. You are the person named on the exam registration form.

2. You will not seek, provide, or obtain any form of unauthorized assistance during the examination orduring breaks.

3. You will not have prohibited materials, including formulas, study materials, notes, papers, orelectronic devices of any kind in your possession while you are in the secured areas of the testingcenter.

4. You will place in a locker, cubicle, or other designated storage area all personal belongings, includingcell phones, watches, pagers, tablet PCs, iPods/media players, fitness and tracking monitors, anydevice with transmitting or receiving capabilities (e.g., Bluetooth), formulas, study materials, notes,papers, pens/pencils, and your purse or wallet, before you enter the testing room.

5. You will leave your testing station for breaks only when the break screen is visible on your monitor.

6. You may use a telephone or other communication device only when outside the secure testing areaand during a scheduled break. You may not use it for any purpose related to test content.

7. You will not remove test content from the testing room by any means.

8. You will maintain the confidentiality of the materials. You will not reproduce or attempt to reproduceexamination materials through recording, memorization, or by any other means. Also, you will notprovide information relating to examination content to individuals who may be taking theexamination. This includes postings on the Internet regarding examination content and/or answers.

9. You will not write on anything other than the laminated note boards provided.

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PERSONAL BELONGINGS IN THE TESTING ROOM Unauthorized personal items are prohibited in the secured testing area. If you bring personal items to the test site, you must store them in the designated storage area; electronic devices must be turned off before storing them. All authorized personal items are subject to inspection.

Prohibited personal items include, but are not limited to the following:

Cell phones

iPads/tablets

Paging devices

iPods/media players

Calculators

Recording/filming devices

Fitness and tracking monitors;

Any device with transmitting or receiving capabilities (e.g., Bluetooth)

Reference materials (books, notes, papers)

Watches with alarms, computer or memory capability

Backpacks, briefcases, luggage, purse or wallet

Beverages or food of any type

Coats, outer jackets, or non-religious headwear

IMPORTANT If you violate these Rules of Conduct, you may be directed to leave the test area before completing your examination. Also, if there is evidence of violation of any test administration rule, including these Rules

of Conduct, CRP reserves the right to take all action — including, but not limited to, barring you from future testing and/or withholding or canceling your scores — for failure to comply with test

administration regulations or the test administrator's directions. If your scores are canceled, they will not be reported and your registration and test fees will not be refunded. Reports of cheating will be

investigated thoroughly and offenders may be prosecuted to the full extent of the law.

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ADMISSION TO THE TEST CHECK-IN PROCEDURES You should arrive at the test site approximately 30 minutes prior to the scheduled start time for the testing session. If you arrive after the testing session has begun, you may not be admitted. If you arrive more than 30 minutes after the start time for the testing session, you will not be admitted.

When you arrive at the test site, you must present a valid, unexpired form of government-issued identification. Your identification must include both your signature and photograph. Your first and last name, as it appears on the roster generated from your exam registration form, must match the name on your form(s) of identification exactly. The name on your identification document must appear in the Latin alphabet (i.e., English language letters).

Acceptable forms of unexpired, government-issued identification include:

Passport

Driver’s license with photograph

National identity card

Military ID

If your government-issued identification does not display a photograph or a signature, a secondary form of identification may be used. This secondary identification must include your name and a photograph and/or signature (whichever is missing from the government-issued identification).

Acceptable forms of secondary identification include:

Valid employee ID

Valid credit card with signature

Valid bank (ATM) card

The identification documents must be originals and must be legible and in good condition. The documents cannot be bent, frayed, taped, cracked, or otherwise damaged in any way.

If you are not admitted to the exam please contact support@nbme.org for next steps in getting your testing session rescheduled.

If you do not bring acceptable identification to your exam administration or your first and last name does not match your identification, you will

not be admitted to the testing session.

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SECURITY PROCEDURES Before you enter the test room, you will be provided with one laminated note board and one dry-erase marker. You also will be provided with your Log-in information for launching the exam. You are permitted to make calculations or notes only on this note board, and only after you have entered your exam start-up code and log-in information (provided by the proctor) to start your testing session on your computer. You can use both sides of the note board. If you need additional space for making notes, you should notify a proctor. The proctor will collect the “filled” note board and replace it with a new one. Do NOT write on anything other than the laminated note board (e.g., your hand or other body part, scrap paper, etc. The laminated note boards will be collected at the end of the testing session.

BREAK TIME SCHEDULED BREAKS There is a scheduled 15-minute break between the third and fourth test block of the CRP exams. A “Break” screen will appear when you have completed the third block or if the timing has elapsed for that test block. The break is optional. If you do not wish to take a break, or if you take less than the time allowed for the break, you can select the Next button, which appears on the “Break” screen, to continue to the next block. If you should take a break that is longer than the time allowed, the clock for the next block will begin. If you take less than the allotted time to complete the test block, additional time WILL NOT be added to the break time or to any of the other test blocks.

UNSCHEDULED BREAKS You are not allowed to take a break during a test block. However, if it becomes necessary to do so (e.g., for a personal emergency), you will be instructed to click the Pause button on the testing screen. Your testing time will continue to expire while you are on an unscheduled break. You will be directed to select Cancel on the screen when you return and are ready to resume testing. The proctor will be instructed to file a report regarding anyone who leaves the testing room during a test block.

Each time you leave the testing room, you are required to present your identification upon your return.

The examinee overview screen (explained in the tutorial on test day) is useful for keeping track of your test session time.

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STARTING AND COMPLETING THE TEST The test session ends when you have started and exited all blocks or the total test time expires. After you start taking an examination, you cannot cancel or reschedule that examination. If you experience a computer issue during the test, notify the test site proctor immediately. The testing software is designed to restart the test at the point that it was interrupted.

In the rare event that a technical problem occurs that does not permit you to complete your examination, you should send a written description of the incident to the NBME at crptestadmin@nbme.org. Your notification must be received within 10 business days of your testing date or it may not be possible to fully investigate your concerns. Your correspondence should include your name, your candidate ID#, the examination name (Monitors, Associates, and Coordinators Certification Exam or Investigators and Scientists Certification Exam), date of examination, and a detailed description of the difficulty experienced. Please allow at least 15 business days for your report to be investigated and evaluated. You will receive written notification of the investigation results.

For more information on how to report a test administration problem, visit the Communicating with CRP section of this bulletin.

CANCELLING OR RESCHEDULING YOUR EXAM

NOTE: The NBME makes every effort to properly process your registration information and to ensure that the examinations are properly prepared, administered, and scored. In the unlikely event that an error occurs in the preparation, processing, administration, or scoring of your CRP examination or in the reporting of your CRP scores, NBME will make reasonable efforts to correct the error, if possible, or permit you either to retest at no additional fee or to receive a refund of the examination fee. These are the exclusive remedies available to examinees for errors in the registration process; in preparing, processing, or administering exams; or in determining or reporting scores.

If you wish to reschedule or cancel you exam administration you must contact support@nbme.org at least 30 days prior to your scheduled exam administration.

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SCORING AND SCORE REPORTING

SCORE REPORTING

SCORE AVAILABILITY Results for both the Monitors, Associates, and Coordinators Certification Examination and the Investigators and Scientists Certification Examination are typically available four to six weeks after the test date. However, release of results may take longer for various reasons. In selecting your test date and inquiring about results, you should allow at least five weeks to receive notification that your score report is available. When your score is available, you will receive an e-mail notification with retrieval instructions.

REPORTING TO THIRD PARTIES Your performance information will be made available to the organization that sponsored your exam. Examination data (including performance information) from the CRP examinations may be used by the CRP program or made available to third parties for research. In such instances, the data will be confidential and individual examinees will not be identified in any publication.

INCOMPLETE SCORES In order to receive a score, you must open every block of the examination. If you do not open every block, your examination will not be scored.

To avoid misinterpretation and to protect your privacy, NBME does not provide scores or outcomes by telephone, e-mail, or fax to anyone. Additionally, the scoring process is not expedited or accelerated for any individual or group.

SCORE VERIFICATION A change in your score or in your pass/fail outcome based on score verification is an extremely remote possibility. A rigorous process is used, including a double scoring process involving independent scoring systems, to ensure accurate results. However, score verification will be performed if you submit a request and service fee. The process to submit a score verification request will be outlined when you receive your score feedback report. The score reported to you will be verified against our official records.

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SCORE VALIDITY The performance of examinees is monitored and may be analyzed to detect aberrancies that raise questions about the validity of scores. The CRP program reserves the right to cancel scores that are at or above the passing level if the CRP program has a good faith basis for questioning whether they represent a valid measure of knowledge or competence as sampled by the examination. If there are questions related to the validity of your score, your score report may be delayed, or any further reporting or verification of such scores may be withheld, pending completion of further review and/or investigation. You will have an opportunity to provide information that you consider relevant.

After review and analysis of all available information, scores will be classified as valid and will be reported, or scores will be canceled and will not appear on your record. If scores are canceled, you will be advised of the options for retaking the examination. Anyone, including third parties, who have received a report of scores that are later cancelled, will be notified.

ANOMALOUS PERFORMANCE Anomalous performance and/or unusual testing history may impact your access to the CRP. If your performance raises concerns about your readiness to test or your motivation to pass, the CRP program reserves the right to restrict your future access to its examinations and/or impose conditions upon future access. Do not test if you are not able or not ready on your scheduled test date.

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SECURITY & INTEGRITY OF THE CRP EXAMINATIONS

EXAMINEE RESPONSIBILITIES The examination materials used in the CRP examinations are the confidential, copyrighted property of the NBME. If you reproduce and/or distribute examination materials, by any means, including reconstruction through memorization, without the express written consent of the NBME, you are in violation of the rights of the owners. Every legal means available to protect NBME examination materials and secure redress against those who violate copyright law may be pursued. CRP reserves the right to take all action—including, but not limited to, barring you from future testing and/or withholding or canceling your scores—for failure to comply with test administration regulations or the test administrator's directions. If your scores are canceled, they will not be reported and your registration and test fees will not be refunded. Reports of cheating will be investigated thoroughly and offenders may be prosecuted to the full extent of the law.

The confidentiality of examination content must be maintained at all times. You are prohibited from communicating, publishing, reproducing, or transmitting any part of your exam, in any form, or by any means, verbal or written, for any purpose.

WEB-BASED EXAMINATION ADMINISTRATIONS AT YOUR INSTITUTION The NBME provides a web-based utility that checks both hardware and software configurations and downloads a plug-in that “secures” the browser. The computer is “locked down,” preventing the examinee from accessing applications such as e-mail or notepad. It also includes a function designed to detect any recording applications and programs that may be running on workstations or examinees’ personal laptops prior to the start of the exam.

CONTACTING NBME ABOUT A SECURITY CONCERN NBME encourages you to provide information concerning any activity of which you are aware that may compromise the security and integrity of the NBME’s examinations. Please contact NBME using our contact form to report such information.

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EXAMINATION CONTENT OUTLINES Content Domain % of Monitor/

Associate/ Coordinator Exam

% of Investigator/ Scientist Exam

Ethics 10%-12% 15%-17% History (e.g., Belmont Report, Declaration of Helsinki) Equipoise Therapeutic misconception Assessment of risks & benefits Vulnerable populations Privacy & confidentiality

Regulations & Guidance 20%-22% 20%-22% FDA Form 1572, investigator agreement (for devices) 21 CFR Parts (50, 54, 56, 312, 314, 807, 812, 814); 45 CFR 46 ICH E6 – Good Clinical Practice Institutional Review Boards GINA (genetics) & tissue banking Trial registration

Study Design & Statistics 5%-7% 14%-16% Study types & subject assignment designs Study flow from pre-clinical through post-market Protocol design Data safety monitoring boards & data management cmtes Study populations & controls Blinding & randomization Basic statistical concepts

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Content Domain % of Monitor/ Associate/ Coordinator Exam

% of Investigator/ Scientist Exam

Study Conduct 30%-32% 24%-26% Financial aspects Qualifications of study team & delegation of authority Study feasibility Subject recruitment & selection Record keeping Reporting adverse events & deviations Standard operating procedures Drug accountability & IP management Corrective action-preventive action Subject withdrawals, early terminations Patient reported outcomes & clinical outcomes assessment Consent process & consent form Compliance Audits, inspections

Safety 14%-16% 14%-16% Serious adverse event & adverse event causality Timeliness and requirements of reporting Risk evaluation and mitigation strategy (REMS) Investigator's Brochure Site monitoring including risk-based monitoring

Data Management 20%-22% 9%-11% Source documents Case report forms Electronic data capture (eDC) Missing data 21 CFR 11 (rules for electronic records and signatures) Data security (methods)

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SAMPLE CLINICAL RESEARCH PROGRAM EXAM ITEMS 1. A 48-year-old woman with stage III breast cancer is referred to an oncologist participating in a

Phase 2 clinical trial testing a novel chemotherapy agent. Based on the review of the patient's medicalhistory and current status, it is determined that she would likely meet entry criteria for the clinicalresearch trial. During the initial interview the investigator tells the patient, "If my wife had a similartype of breast cancer, I would enroll her in the trial." After hearing this information, the patientdecides to enroll in the clinical trial. Which of the following best describes this investigator's actions?

(A) Clinical equipoise (B) Coercion (C) Enrollment of a vulnerable population (D) Therapeutic misconception

Answer: B

2. Early studies of a new hemolytic anemia drug suggest therapeutic efficacy combined with a reducedadverse event profile compared to existing standard therapies. During the consent process for thecurrent Phase 3 trial, a potential subject asks about the study drug’s known side effects. Which of thefollowing is the most appropriate response by the research nurse?

(A) Assure the potential subject research staff will carefully monitor for side effects during the study

(B) Explain that the study has been reviewed and approved by the Institutional Review Board for safety

(C) Point to and discuss the side effects listed on the informed consent form (D) Tell the potential subject that the drug does not have as many side effects as currently FDA-

approved medications Answer: C

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3. An investigator in a study protocol of a new type of arm sling is a voting member of his hospital'sInstitutional Review Board (IRB). Which of the following is the most appropriate action by theinvestigator during review of the protocol by the IRB?

(A) Recuse himself from the vote and leave the room during deliberations (B) Serve as the IRB's scientific advisor about the study and also vote on the protocol (C) Vote to accept the protocol, as it is a minimal-risk device (D) Vote to accept the protocol, as long as he informs other IRB members that there may be a

conflict of interest Answer: A

4. In addition to having a minimum of five members, which of the following is a requirement for anInstitutional Review Board?

(A) Multiple female members and one member who is affiliated with the institution (B) One member who is an ear-nose-throat specialist and one member whose primary interest is in

a non-scientific area (C) One member who is a hospital administrator and one member whose primary interest is in a

non-scientific area (D) One member whose primary interest is in a non-scientific area and one member who is not

affiliated with the institution Answer: D

5. Clinical outcome and demographic data from 150 patients with dengue fever are collected frompatient charts to determine if there is an association between this condition and fasting. The affectedpatients are matched by age, sex, and race to 300 patients without dengue fever. The hospital chartsof the patients in each group are then reviewed to determine if they fasted prior to the illness. Thisstudy is an example of which of the following types of design?

(A) Case-control (B) Concurrent cohort (C) Cross-sectional (D) Retrospective cohort

Answer: A

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6. A principal investigator (PI) reviews the informed consent form (ICF) with a potential subject ina clinical trial of an investigational new drug for diabetes mellitus. During the process, the subjectappears uneasy and nervous and says that she is not sure if her spouse would agree with herparticipation in the trial. Which of the following is the most appropriate response by the PI?

(A) If the subject does not sign the ICF today, she cannot participate in the trial (B) The subject can sign the ICF now and talk to her spouse before the trial begins (C) The subject can talk to her spouse and sign the ICF at a later date (D) The subject should provide her spouse's phone number so the PI can convince him

Answer: C

7. Which of the following best describes the main objective of establishing exclusionary criteria?

(A) Ensure the safety of subjects (B) Exclude incapacitated subjects (C) Improve diversity among subjects (D) Increase the potential power calculation

Answer: A

8. For competent adults participating in a clinical research study, written consent forms should betargeted at which of the following reading levels?

(A) 8th grade (B) 9th grade (C) 10th grade (D) 11th grade (E) 12th grade

Answer: A

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9. A subject is enrolled in a study of an investigational new drug designed to treat bacterial vaginosis.

The subject returns for a day 14 visit and says that she experienced an episode of intractable nausea and vomiting, which resulted in an emergency department visit. The subject was discharged after intravenous fluids were administered and an antiemetic medication was provided. She reports that the symptoms lasted 48 hours and that she used the antiemetic medication only twice. She states that a “stomach bug” was circulating at work during that time. The principal investigator (PI) reviews the informed consent form and Investigator’s Brochure and notes that “mild to moderate nausea and vomiting” are listed as possible adverse events. Which of the following is the most appropriate next step in documenting this event?

(A) Adverse event of nausea and vomiting, possibly related to study drug (B) Nausea and vomiting, unrelated to study drug (C) Serious adverse event, possibly related to study drug (D) Severe adverse event, possibly related study drug

Answer: A

10. An electronic case report form must include which of the following?

(A) Automatic upgrades to software (B) Integration into the institution’s electronic medical record (C) Link to an Internet protocol address registered with the FDA (D) Remote access by the study sponsor (E) Secure tracking of all entries and changes

Answer: E

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SAMPLE SCORE REPORT AND INTERPRETATION GUIDE

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SAMPLE EXAMINEE ELIGIBILITY COVERSHEET

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