CKA Test Guide

Four Easy Steps to Take the Test

Step 1: Complete the CKA application and select one of more than 170 U.S. or International Assessment Centers.

Step 2: Mail your application and payment to ACRP's Global Headquarters.

Step 3: Schedule your test. Once your application and payment have been received and approved, Applied Measurements Professionals, our testing agency, will e-mail you a link to access the procedure for scheduling your test.

Step 4: Take your test online and receive your results immediately.

Test Requirements

There are no prerequisites to take the CKA test. We do strongly recommend that a candidate take an introductory education course in the fundamentals of clinical research.Confirmation: Complete the test application on the ACRP website. You can register online or print the application and mail or fax with payment. ACRP will send your application information to Applied Measurement Professionals (AMP), our testing agency, and they will send you a link to schedule taking the CKA test at the site of your choice.

Timed Test

Following the practice test, you will begin the timed test. Before beginning, instructions for taking the test are provided on-screen.

The computer monitors the time you spend on the test. You will have 90 minutes to complete the test. The test will terminate if you exceed the time allowed. You may click on the "Time" box in the lower right-hand corner of the screen or select the Time key to monitor your time. A digital clock indicates the time remaining for you to complete the test. The Time feature may be turned off during the test.

Fees

CKA Test	$185
CKA and Join ACRP	$305
CKA and Join APPI	$485

Cancellation/Refund/Transfer Policy

There are no refunds for canceling the test. A candidate may reschedule an appointment for testing at no charge once by calling AMP at 888-519-9901 at least two business days prior to the scheduled testing session.

Scheduling the Test

Once you have applied to take the CKA and received the link from AMP, you may schedule a test appointment by one of the following methods. Be prepared to confirm a date and location for testing and to provide your unique identification number. That number is your ACRP Membership number plus as many zeros as it takes to equal nine numbers. The zeros will precede your ID number. Example, if your ID number is 12345, your unique number will be 000012345.

Schedule Online: The candidate may schedule a test appointment online at any time by using our Online Scheduling service at www.goAMP.com. To use this service on our website, follow these easy steps:

• Go to www.goAMP.com and select "Candidates."
• Follow the simple, step-by-step instructions to choose your test program and schedule the test.

OR

Telephone Scheduling: Call AMP at 888-519-9901 to schedule a test appointment. This toll-free number is answered from 7:00 a.m. to 7:00 p.m. (Central Time) Monday through Thursday, 7:00 a.m. to 5:00 p.m. on Friday and 8:30 a.m. to 5:00 p.m. on Saturday.

If special accommodations are being requested, please submit the Request for Special Test Accommodations form prior to contacting AMP at 888-519-9901 to schedule your test.

The tests are administered by appointment only Monday through Friday at 9:00 a.m. and 1:30 p.m. Individuals are scheduled on a first-come, first-served basis. Refer to the chart below.

If you contact AMP by 3:00 p.m. Central Time on… Depending on availability, you may be scheduled as early as… Monday Tuesday Wednesday Thursday Friday Thursday Friday Monday Tuesday Wednesday

When the appointment is made, the applicant will be given a time to report to the Assessment Center. AMP will send a confirmation email. The applicant will only be allowed to take the test for which the appointment has been made. No changes in test type will be made at the Assessment Center. UNSCHEDULED CANDIDATES (WALK-INS) WILL NOT BE ADMITTED to the Assessment Center.

Assessment Center Locations

Tests are administered by computer at over 160 AMP Assessment Centers geographically distributed throughout the United States and Canada. There are currently 18 international Assessment Centers. Assessment Center locations, detailed maps and directions are available on AMP's website, www.goAMP.com. Specific address information will be provided when a candidate schedules a test appointment.

Holidays

The tests are not offered on the following holidays:

• New Year's Day
• Martin Luther King Day
• Presidents' Day
• Good Friday
• Memorial Day
• Independence Day (July 4)
• Labor Day
• Columbus Day
• Veterans' Day
• Thanksgiving Day (and the following Friday)
• Christmas Eve Day
• Christmas Day
• New Year's Eve Day

Special Arrangements for Candidates with Disabilities

AMP complies with the Americans with Disabilities Act and strives to ensure that no individual with a disability is deprived of the opportunity to take the test solely by reason of that disability. AMP will provide reasonable accommodations for candidates with disabilities. Candidates requesting special accommodations must call AMP at 888-519-9901 to schedule their test.

1. Wheelchair access is available at all established Assessment Centers. Candidates must advise AMP at the time of scheduling that wheelchair access is necessary.
2. Candidates with visual, sensory or physical disabilities that would prevent them from taking the test under standard conditions may request special accommodations and arrangements.

Verification of the disability and a statement of the specific type of assistance needed must be made in writing to AMP at least 45 calendar days prior to your desired test date. Please inform AMP of your need for special accommodations when scheduling your test time.

Telecommunication Devices for the Deaf

AMP is equipped with Telecommunication Devices for the Deaf (TDD) to assist deaf and hearing-impaired candidates. TDD calling is available 8:30 a.m. to 5:00 p.m. (Central Time) Monday-Friday at 913/495-4437. This TDD phone option is for individuals equipped with compatible TDD machinery.

Test Appointment Changes/Failure to Report or To Schedule a Test

A candidate may reschedule an appointment for testing at no charge once by calling AMP at 888-519-9901 at least two business days prior to the scheduled testing session. (see table below.)

If the Test is scheduled on … AMP must be contacted by 3:00 p.m. Central Time to reschedule the Test by the previous … Monday Tuesday Wednesday Thursday Friday Tuesday Wednesday Thursday Friday Monday

A candidate who wishes to reschedule his/her test appointment, but fails to contact AMP at least two business days prior to the scheduled testing session will forfeit the test fee and must reapply to take the test.

Inclement Weather, Power Failure or Emergency

In the event of inclement weather or unforeseen emergencies on the day of a test, AMP will determine whether circumstances warrant the cancellation and subsequent rescheduling, of a test. The test will usually not be rescheduled if the Assessment Center personnel are able to open the Assessment Center. If power to an Assessment Center is temporarily interrupted during administration, your test will restart where you left off and you may continue the test.Candidates may contact AMP's Weather Hotline at 913/495-4418 (24 hours/day) prior to the test to determine if AMP has been advised that any Assessment Centers are closed. Every attempt is made to administer the test as scheduled; however, should a test be canceled at an Assessment Center, all scheduled candidates will receive notification following the test regarding rescheduling or reapplication procedures

On the Day of Your Test

On the day of your test appointment, report to the Assessment Center no later than your scheduled testing time. Once you enter the Assessment Center, look for the signs indicating AMP Assessment Center check-in. A CANDIDATE WHO ARRIVES MORE THAN 15 MINUTES AFTER THE SCHEDULED TESTING TIME WILL NOT BE ADMITTED.

To gain admission to the Assessment Center, a candidate needs to present two forms of identification, one with a current photograph. Both forms of identification must be current and include the candidate's current name and signature. The candidate will also be required to sign a roster for verification of identity.

Acceptable forms of identification include a current:

1. Driver's license with photograph State identification card with photograph Passport Military identification card with photograph
2. Social security card (secondary form)

Employment ID cards, student ID cards and any type of temporary identification are NOT acceptable as primary identification. Candidates are prohibited from misrepresenting their identities or falsifying information to obtain admission to the Assessment Center.

Security

ACRP and AMP maintain test administration and security standards that are designed to assure that all candidates are provided the same opportunity to demonstrate their abilities. The Assessment Center is continuously monitored by audio and video surveillance equipment for security purposes.

The following security procedures apply during the test:

• Tests are proprietary. No cameras, notes, tape recorders, Personal Digital Assistants (PDAs), calculators, pagers or cellular phones are allowed in the testing room. No calculators are permitted. No guests, visitors or family members are allowed in the testing room or reception areas.
• No personal items, valuables, or weapons are allowed in the Assessment Center. Only keys and wallets may be taken into the testing room and AMP is not responsible for items left in the reception area.

Test Restrictions

• No personal belongings will be allowed in the Assessment Center. Pencils will be provided during check-in. Use of a cellular phone or other electronic devices is strictly prohibited and will result in dismissal from the test. You will be provided with scratch paper to use during the test. You must sign and return the scratch paper to the supervisor at the completion of testing, or you will not receive a score report. No documents or notes of any kind may be removed from the test room. If you need a second piece of scratch paper, you need to ask the test proctor for another piece of paper and turn in the one you used before. No questions concerning the content of the test may be asked during the test. Eating, drinking or smoking will not be permitted in the Assessment Center.
• You may take a break whenever you wish, but you will not be allowed additional time to make up for time lost during breaks.

Misconduct

Individuals who engage in any of the following conduct may be dismissed from the test, their scores will not be reported and test fees will not be refunded. Examples of misconduct are when a candidate:

• creates a disturbance, is abusive, or otherwise uncooperative; displays and/or uses electronic communications equipment such as pagers, cellular phones, PDAs; gives or receives help or is suspected of doing so; attempts to record Test questions or make notes; attempts to take the test for someone else; or
• is observed with notes, books or other aids.

Copyrighted Test Questions

All test questions are the copyrighted property of ACRP. It is forbidden under federal copyright law to copy, reproduce, record, distribute or display these test questions by any means, in whole or in part. Doing so may subject you to severe civil and criminal penalties.

Practice Test

After your identification has been confirmed, you will be directed to a testing carrel. You will be instructed on-screen to enter your unique identification number. You will take your photograph which will remain on screen throughout your test session. This photograph will also print on your score report.Prior to attempting the test, you will be given the opportunity to practice taking a test on the computer. The time you use for this practice test is NOT counted as part of your test time or score. When you are comfortable with the computer testing process, you may quit the practice session and begin the timed test. Please note that this practice test is to help you become familiar with the computerized test format; it is possible that the questions will not be clinical research related.

Timed Test

Following the practice test, you will begin the timed test. Before beginning, instructions for taking the test are provided on-screen.The computer monitors the time you spend on the test. You will have 90 minutes to complete the test. The test will terminate if you exceed the time allowed. You may click on the "Time" box in the lower right-hand corner of the screen or select the Time key to monitor your time. A digital clock indicates the time remaining for you to complete the test. The Time feature may be turned off during the test.Only one test question is presented at a time. The question number appears in the lower right hand corner of the screen. Choices of answers to the test question are identified as A, B, C, or D. You must indicate your choice by either typing in the letter in the response box in the lower left hand of the computer screen or clicking in the option using the mouse. To change your answer, enter a different option by pressing the A, B, C, or D key or by clicking on the option using the mouse. You may change your answer as many times as you wish during the test time limit.To move to the next question, click on the forward arrow (>) in the lower right portion of the screen or select the NEXT key. This action will move you forward through the test question by question. If you wish to review any question or questions, click the backward arrow (<) or use the left arrow key to move backward through the test.An test question may be left unanswered for return later in the test session. Questions may also be bookmarked for later review by clicking in the blank square to the right of the Time button. Click on the hand icon or select the NEXT key to advance to the next unanswered or bookmarked question on the test. To identify all unanswered and bookmarked questions, repeatedly click on the hand icon or press the NEXT key. When the test is completed, the number of test questions answered is reported. If not all questions have been answered and there is time remaining, return to the test and answer those questions. Be sure to provide an answer for each test question before ending the test. There is no penalty for guessing.

Candidate Comments

During the test, online comments may be provided for any question by clicking on the button displaying an exclamation point (!) to the left of the Time button. This opens a dialogue box where comments may be entered. Comments will be reviewed, but individual responses will not be provided.

Following the Test

After completing the test, candidates are asked to complete a short evaluation of their test experience. Then, candidates are instructed to report to the test proctor to receive their test completion report. This document should be kept in your personal records as it is proof of your scores.

Pass/Fail Score Determination

The methodology used to set the minimum passing score is the Angoff method, based upon data gathered during the performance of a Passing Point Study by a panel of experts in the field. The experts evaluated each question on the test to determine how many correct answers are necessary to demonstrate the knowledge and skills required to pass this test portion. Your ability to pass the test depends on the knowledge and skill you display, not on the performance of other candidates.Passing scores may vary slightly for each version of the test to accommodate for variences in test difficulty. To ensure fairness to all candidates, a process of statistical equating is used.. Slight variations in difficulty level are addressed by adjusting the passing score up or down, depending on the overall difficulty level statistics for the group of scored questions that appear on a particular version of the test.

Scores Cancelled By the Client or AMP

ACRP and AMP are responsible for the validity and integrity of the scores they report. On occasion, occurrences, such as computer malfunction or misconduct by a candidate, may cause a score to be suspect. ACRP and AMP reserve the right to void or withhold test results if, upon investigation, violation of its regulations is discovered.

Confidentiality

Information about candidates for testing and their test results are considered confidential. Studies and reports concerning candidates will contain no information identifiable with any candidate, unless authorized by the candidate.

Duplicate Score Report

Candidates may purchase additional copies of their results at a cost of $25 per copy. Requests must be submitted to ACRP, in writing. The request must include the candidate's name, unique identification number, mailing address, telephone number, date of test and test taken. Submit this information with the required fee payable to ACRP in the form of a check, money order or cashier's check. Duplicate score reports will be mailed within approximately two weeks after receipt of the request and fee.

CKA Detailed Content Outline (DCO)

1. Clinical Research Overview  (15 items)
   
   a. ICH Guideline
   b. Protection of Human Subjects/ informed consent
   c. General Principles of Clinical Research/GCP
   
   
2. Investigational Product Research and Development (11 items)
   
   a. Discovery and Preclinical Research
   b. Investigational New Drugs
   c. Medical Devices
   d. Biologics
   e. Post-marketing
   
   
3. Clinical Research Methodology (24 items)
   
   a. Trial Design
   b. Research Protocols
   c. Source Documents
   d. Case Report Forms
   e. Regulatory Documents
   f. Investigator’s Brochure
   g. Trial conduct
   
   
4. Roles and Responsibilities (15 items)
   
   a. IRB/IEC
   b. Investigator/staff
   c. Sponsor/monitor
   d. CRO
   
   
5. Safety Reporting (10 items)
   
   a. Definitions
   b. Standards for Reporting

Test Preparation and References

Studying the following ICH guidelines (www.ich.org) will assist you in preparing for the test:

• Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A) Good Clinical Practice (E6) General Considerations for Clinical Trials (E8)
• The Declaration of Helsinki

All of the questions are multiple choice and are at the Recall level of complexity. Recall questions primarily test the recognition of isolated information. They include the recall of specific facts, concepts or principles.

Sample Test Questions

1. Please refer to the Detailed Content Outline III.g.

Which of the following would normally take place at a pre-study visit?

1.  Source document review
2. Review of protocol with an IEC member
3. Assessment of the site’s equipments relevant for the study
4. Discussion of the storage and distribution requirements for the investigational product

A.  1 and 2 only
B.  3 and 4 only
C.  2 and 4 only
D.  1 and 3 only

The correct answer is B; 3 and 4 only.

Explanation:
(I) There cannot be any review of Source Documentation at the pre-study visit because the study has not yet started at the site
(II) The purpose of the visit is to decide whether a site is suitable to conduct a study. The criteria are essentially the experience and availability of the investigator and other personnel and the facilities available including essential equipments. Discussions between the CRA and the ethics committee are not standard practice.

2. Please refer to the Detailed Content Outline I.a.

The ICH GCP Guidelines require a PI to provide an IEC with all of the following EXCEPT

A.  Information about payments to subjects
B.  Significant changes in the protocol
C.  Information regarding all serious unexpected Adverse Drug Reactions
D.  Names of subjects prematurely terminated from the study ANSWER

The correct answer is D; names of subjects prematurely terminated from the study.

Explanation:
This question asks for the recognition of only the wrong answer.
(A) is stated in ICH GCP s3.1.8
(B) is stated in ICH GCP s3.1.2
(C) is stated in ICH GCP s3.3.8.c

3. Please refer to the Detailed Content Outline V.b.

An event that has been associated with the use of the test article and is documented  in the Investigator's Brochure is defined as:

A. mild
B. severe
C. serious
D. expected

The correct answer is D; expected

Explanation:
The applicable product information (e.g, Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product) describes the possible risks and adverse drug reactions to be expected on the basis of prior experiences with the product under investigation and with related products.
Ref: ICH GCP 1.60; 7.3.6