Society for Clinical Data Management

CERTIFICATION HANDBOOK

Introduction
Thank you for your interest in the Society for Clinical Data Management’s (SCDM) Certified Clinical
Data Manager (CCDM®) examination and for choosing SCDM as your certifying organization.

About SCDM SCDM Core Values

The Society for Clinical Data Management Knowledge and Experience of our
(SCDM) is a non-profit professional Members
society founded to advance the discipline The intellectual capital and collective
of Clinical Data Management. The binding experience of our members are our greatest
interest of all members is quality clinical assets. SCDM relies on and embraces the
data management practices. participation and contributions of our
members and volunteers.
SCDM was founded in 1994 and has Scholarship
grown to be a premier data management SCDM encourages and promotes rigor and
organization which embodies upwards of discipline in the research of topics affecting
2300 domestic and international members our industry. Our positions, publications and
who represent the biotechnology, medical programs are the result of scholarly
device and pharmaceutical industries; as investigation.
well as members of the academic, Quality and Continuous Improvement
regulatory and scientific research SCDM is committed to the development and
communities. Third party organizations enhancement of products, services and
that support these groups include: Contract relationships of the highest quality.
Research Organizations, consultants, Open Communication
hardware and software vendors and SCDM encourages open communication and
placement firms and represent an information sharing. We provide our
important portion of the Society’s members with insight to the organization’s
membership. initiatives and activities.
Integrity
SCDM exemplifies and expects honesty and
integrity.

SCDM Certification Philosophy

The Society for Clinical Data Management established the certification program for clinical data
managers to institute a standard of knowledge, education and experience by which clinical data
managers would be professionally recognized by the medicinal, biological development and
medical device therapies community. Through a rigorous application and examination process
certified clinical data management professionals are able to demonstrate a high level of
competence and expertise in their field.

The SCDM certification program was designed to meet the following goals:
• Establish and promote professional practice standards throughout clinical data
management
• Identify qualified professionals within the profession
• Ensure recognition of expertise
• Enhance the credibility and image of the profession
 Society for Clinical Data Management

About the CCDM® Exam

The CCDM® exam, revised and released in September 2008, contains 130 multiple choice
questions and are allotted 3.5 hours for this exam.

Application Process
Certification application is available online:
https://www.scdm.org/certification/application/Default.aspx An application is also included in
the back of this handbook and marked as Appendix 1.

Please send all certification applications to:

Society for Clinical Data Management
555 E. Wells Street, Suite 1100
Milwaukee, WI 53202
U.S.A

What are the Costs?

The cost to sit for the SCDM CCDM® exam is $195.00 U.S. dollars. The Society for Clinical
Data Management will accept a check, money order or credit card.
**Note: if we are unable to process your application, a portion of the application fee less
administrative costs, will be returned to you. However, once your application is accepted, the
fee is nonrefundable.

Certification Application Status

Once your application has been processed, approximately 14 days after it is submitted, you will
receive a letter of acceptance, denial, or a request for further information. The letter of
acceptance will include an eligibility ID required to schedule your exam. You will have 90 days
from the date of your acceptance letter to take your exam. The “90 days” is referred to as your
eligibility period. We recommend that you schedule your exam immediately upon receipt of your
acceptance letter.

Rejection of Certification Application

Applicants must meet at least one of the eligibility requirements listed on the Eligibility
Requirements Document marked as Appendix 2. If an applicant does not meet the requirements,
they will be entitled to a full refund.

Testing Agency
The certification exam will be offered at Prometric test centers, the professional testing agency
secured by contract to assist SCDM in the administration, scoring and analysis of the
certification examination throughout North America and Internationally. Once your application
has been accepted, you will schedule the date and time of your exam directly through Prometric.

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What to provide when scheduling your exam

Candidates must provide Prometric with eligibility ID number, exam name and preferred exam
date when making an appointment. Prometric will only schedule appointments for paid exam.
When
Candidates make an appointments, Prometric will provide instructions about ID requirements
and test center locations.

Scheduling Your Exam

To schedule your exam on-line access the Prometric website www.prometric.com
In the United States and Canada, Prometric will use best efforts to provide Candidates with a test
seat within fifty (50) miles and thirty (30) days of his/her requested date and location. Outside
the United States and Canada, Prometric will make reasonable efforts to provide each Candidate
a test seat within one hundred (100) miles and thirty (30) days of his/her requested date and
location.

Thirty (30) days is defined as fifteen (15) calendar days before Candidate’s requested
appointment and fifteen (15) calendar days after Candidate’s requested appointment.

Extensions
Applicants may request an extension of their eligibility period due to serious medical reasons,
personal tragedy, or unforeseen event. The following rules apply:

Must request extension two weeks prior to scheduled examination (if possible)

Must be seriously ill (or member of immediate family seriously ill)
Documentation may be requested
Applicants must contact the SCDM office directly for all extensions by phone, mail, or email.

No Show, Late Arrival and Rescheduling

The Exam Cancellation/Change Deadline for any exam that has been scheduled is as follows:

United States and Canada will need 2 business days notice prior to exam before noon
EST

Outside the US and Canada will need 5 business days notice prior to exam before noon
Regional Registration Center (RRC) time

Cancellations/changes must be made and confirmed direct contact with RRC, CSCC or test site
personnel, or through the Prometric Registration Website. Leaving a message on a recorder or a
voice mail (except through the IVR system) is not sufficient to confirm cancellation/change.

Once the Candidate has registered and is scheduled for an appointment time at a Prometric test
site, the Candidate cannot transfer his or her appointment to another Prometric test site that is not
served by the same Regional Center.

Candidates will be charged the entire certification exam fee in the event that they negligently “no
show” for the certification exam. SCDM realizes that there are extreme cases, i.e. sudden illness,

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death of an immediate family member or an accident on the way to the exam that prohibits you
to sit for the exam. Candidate will be expected to present a physician’s note, death
certificate/obituary, police/accident report, or other valid documentation to reschedule. Candidate
will be assessed a fee to reschedule the exam. This fee covers SCDM costs for adjusting
eligibility and registration records.

What to expect when you get to the Test Site

Identification and Check-in
Prometric check-in procedures will include Candidate identification verification either through
verification of one photo ID containing a signature or verification of one signature ID. Prometric
will require all Candidates to sign a Prometric logbook. Signature in the logbook will be checked
against the Candidate ID signature. Candidates will be required to sign the logbook upon
completion of the Exam as well as at check-in.

If Candidate has no valid ID, Candidate must, prior to an appointment, arrange with SCDM for
approval of an alternate form of ID. SCDM will in-turn contact Prometric at a telephone number
designated by Prometric before Candidate's scheduled appointment date specifying exactly what
ID is acceptable. Candidates who do not produce a valid ID at the scheduled appointment will
not be allowed to take the Exam.

Candidates will be charged a cancellation fee equal to the Per-Exam Delivery Charge for the
appointment time scheduled, and Candidate will not receive a refund of the Candidate testing
fee. If Candidate arrives more than fifteen (15) minutes late for a scheduled appointment, the test
center staff may choose not to seat the Candidate if doing so disrupts the test center's other
scheduled appointments. If the test center staff does not seat the Candidate, due to late arrival,
there will be no refund of the Candidate testing fee.

Taking the test

There is ample time (3.5 hours) allocated to take the test. During the exam, you are permitted to
take unscheduled breaks, however please note, the clock will not stop. You should plan to bring
a snack or beverage with you since these provisions may not be available at all test centers.

Equipment provided at the test center

Minimum standard test center equipment is a Pentium based computer with at least a 100 Mhz
CPU, 32 MB RAM, 17" SVGA Color Monitor, 8Mb Video RAM, Creative Sound Blaster Sound
Card, and headphones (for listening to passages during an assessment). Workstation Operating
System is Windows 98. The certification exam is compatible with these operating parameters.

ADA Compliance
The physical construction of test centers located in the United States will at all times conform in
all material respects to the standards established by the Americans with Disabilities Act of 1990
(ADA). The test centers located outside the United States will make reasonable efforts to

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accommodate Candidates in a manner substantially similar to the standards of ADA, but

Prometric will not guarantee complete conformance with ADA.

In the event special accommodations are needed such as a reader, amanuensis, or signer, the
candidate must contact SCDM for assistance; Prometric testing centers are not required to have
these services available.

Refunds
Once you schedule your test date it will be important that you take the test on your scheduled
date. A fee will be assessed if you miss your scheduled test date without following the
rescheduling procedures listed on the Prometric website.

Preparing for the Exam

SCDM offers a webinar series at least four times per year on topics related to the exam as well as
for professional development. We also offer face to face workshops twice per year in
collaboration with Duke University’s Clinical Research Institute. The Annual Conference
sessions are also a significant source of information and are archived on our website. Finally, the
Good Clinical Data Management

Practices (GCDMP) document is a foundational resource that will also help with exam
preparation and is available in print form and as podcasts.

The SCDM Education Web Portal (http://portal.scdm.org) is an excellence source for additional
resources to help candidates prepare to sit for the exam. This portal includes a self-assessment
tool to help identify areas needing further study and direct users to helpful resources. These
resources will include online short courses, reference materials and the “DataMatters” listserv to
help answer questions and coach people as they study for the exam.

After the Exam

Notification of Results
Upon completion of the exam your results will appear on your screen. You will receive a print
out of your results at the test site.

If you pass the exam

After completing the examination, candidates will receive, via mail, a CCDM® certificate,
CCDM® pin and test results. Those who successfully complete the examination are asked to fill
out a survey which will be incorporated into SCDM publications. Candidates who pass may use
the appropriate credential immediately.

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If you do not pass the exam

The applicant may re-take the exam within one (1) calendar year of the formal notification letter
date of your original exam results. After that, a full application must be submitted and the full fee
structure applies.

The fee to retake the CCDM® exam is $125 (US).

A re-take exam application is available on line and can be found at the back of this handbook, it
is marked Appendix 3.

CCDM® Renewal
SCDM Certified Clinical Data Management professionals (CCDM®s) are required to renew their
certification every three years from the time of their original certification. By renewing,
CCDM®s demonstrate their willingness to continue to advance within the field and commitment
to continued growth in both knowledge and competency in clinical data management.

The CCDM® Renewal application must be submitted along with:

• Renewal or exam fee

• CEU submission form, Appendix 4 (required for non-SCDM CEU courses only)
• CEU certificates from all educational events (Non-SCDM)

The renewal application can be found at the back of this handbook, it is marked Appendix 5.

To renew certification, candidates must acquire a minimum of 1.8 CEUs within 3 years.
This time frame begins from the date of certification until the date the CCDM® eligibility
expires.

Obtaining CEUs through Educational Training and Conferences

SCDM requires that at least 60% of CEUs come from clinical data management (CDM) specific
training.

SCDM allows up to 40% of CEUs to come from Non-CDM specific training such as Society
volunteer activities. SCDM recommends that CEU applicants consider the CCDM® Core
Competencies when choosing any non-CDM specific training. CEU percentage breakdown chart
(Appendix 6)

SCDM will accept CEU certificates* for training completed within organizations that offer
IACET CEUs. CEU certificates must be provided for each training course completed.
Certificates* for CEUs from public/non profit organizations (SoCRA, DIA, ACRP, Universities)

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as well as private organizations (Barnett, EDC and Beyond, etc), will be considered equally;
however, internal company training is not applicable.

CEU certificates for training completed by organizations that do NOT offer IACET CEUs are
accepted only when the applicant has submitted the Non-IACET CEU Affidavit Form to the
SCDM Administrative Office and said provider is approved by SCDM. The affidavit can be
found in the back of this handbook, marked Appendix 7.

* CEU Certificates must include the following:

• Workshop title
• Date of offering
• Name of sponsoring organization
• Specific number of CEUs issued
• Signature and date of representative from sponsoring organization

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Appendix 1

Application for Certified Clinical Data Manager (CCDM®) Examination

Please type or print all information within this application, indicate responses where required, sign in the
appropriate spaces, and return with a check, money order or credit card information for a *non-
refundable application fee of US $195.00 and required enclosures to:

Society for Clinical Data Management

555 East Wells Street, Suite 1100
Milwaukee, WI 53202-3823

In the event that your application is rejected, a portion of your application fee, less
administrative and handling costs, may be returned to you. Once the application is accepted, no
refund will be granted.

Please allow14 days for processing of your application. Upon confirmation of your
qualifications, you will receive a letter with an identification number to present to Prometric to
schedule your examination.

Last Name*______________________ First Name*____________________ MI*___

(*Required field, enter name, as it appears on your passport or photo identification ~ PLEASE
PRINT OR TYPE)

Current Employer: ______________________________________________________________

Title: _________________________________ Department: _____________________________

*Mailing address: _______________________________________________________________

*City_______________________State/Province______________Zip/Postal Code___________

*Daytime Phone: __________________________Evening Phone: ________________________

*Fax: _________________________________*Email: _________________________________

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Appendix 1

Section 1

Have you taken this examination previously?

No
Yes Date__________________

EDUCATION
(Please indicate highest degree earned)
No Degree
BS or BA
MS or MA
PhD
Other___________________

NOTE: Enter degrees obtained in the table below. If you satisfy the maximum experience
requirements of four years or more, then the following degree information is not
required.

EDUCATION RECORD

Educational Institution Year Degree Obtained Degree Obtained

Attended

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Appendix 1

Section 2

WORK EXPERIENCE
(List any relevant positions held and indicate the CDM tasks performed during the time you held
those positions. Reference the CDM task list on the following page.)

NOTE: You must include an updated copy of your resume or CV.

Company Name, Address Supervisor’s or Employment Position CDM Tasks FTE/PTE

and Phone Manager’s Name Dates Title (Please use the list on
the following page as
a guide)

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Appendix 1

* Please use the appropriate “task letter from the CDM Task List” when completing the
Work Experience section on page 3.
Task “CDM TASK LIST”
Letter
A Protocol review
B CRF Design
C Data Management Plan development (includes database specifications, electronic edit checks,
data review guidelines, annotated CRF)
D CRF tracking and inventory
E CRF data verification (data entry discrepancy resolution)
F CRF data validation (i.e. scrubbing , cleaning, query generation, applying data handling
conventions)
G Manual CRF review
H Query resolution (i.e. correspondence with investigator sites to obtain resolution to queries)
I Query tracking
J Communication of data trends
K Database updates
L Safety review
M Coding adverse events/signs and symptoms
N Coding medications
O SAE reconciliation
P Processing local laboratory data (collected via CRF)
Q Processing (loading/merging) central laboratory data
R Maintenance of laboratory normal range information
S Application of randomization schemes to study databases (i.e. breaking the blind)
T Database lock procedures
U Database quality control audits
V Review of final data listings
W Review of final data tables or graphs
X Review of final reports
Y Archiving database and associated documentation
Z CRO management
AA Relational Databases – The data management software and data structures which allows the
user to store and manipulate data from specific studies including capabilities to import and
export specific data from compatible software.
BB Time Management – Utilizing techniques to effectively organize and use own time for the
accomplishment of project and organizational goals.
CC Project Management – Utilizing techniques to effectively organize and manage multi-
disciplinary resources to deliver projects or programs to customer expectations.

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Appendix 1

Section 3

ELIGIBILITY CERTIFICATION
I have read and understand the information in attached Eligibility Requirements Document. I hereby represent
and warrant that I am eligible to apply to take the CCDM® Examination because I meet the eligibility
requirements in the following manner (indicate eligibility category and complete blank if applicable.)
Bachelor’s degree or higher plus 2 or more years full time experience as a CDM
Associate’s degree (2 years) plus 3 or more years full time experience as a CDM
No degree plus 4 or more years full time experience as a CDM

AUTHORIZATION
I hereby authorize the Society for Clinical Data Management (SCDM) to make whatever inquiries it deems
necessary and appropriate to confirm the accuracy of the contents of my application. I agree to provide any
additional authorizations necessary to that process. I hereby authorize SCDM to use the information contained
in my application and examination for purposes of statistical analysis, provided that my personal identifying
information has first been deleted.

APPLICATION INFORMATION
I hereby certify that I have reviewed the information contained in this application and that it is complete and
truthful. I understand that my presenting false or incomplete information may be cause for loss of eligibility to
take the CCDM® examination, for denial of my application for certification or for revocation of any certification
granted.

EXAMINATION
I understand that I may be disqualified from taking or completing the CCDM® examination or from receiving
examination scores if SCDM determines through proctor observation or otherwise that I engaged in
inappropriate behavior during the examination.

CLINICAL DATA MANAGEMENT ACTIVITY

I hereby represent and warrant that I have at all times acted in compliance with the SCDM Code of Ethics and
with those laws and regulations applicable to clinical research, including without limitation, the Declaration of
Helsinki and applicable U.S. Food and Drug Administration regulations. I understand that conduct at all times
in violation of the spirit of the Code of Ethics or applicable laws makes me ineligible to take the certification
examination and can be cause for permanent revocation of my certification status.

TERMS AND CONDITIONS OF USE OF THE CCDM® CERTIFICATION MARK

I hereby agree that, should I become a certified professional, I will abide and be governed by the Terms and
Conditions of Use of CCDM® Certification Mark, a copy of which has been provided to me.

Candidate’s Signature: ___________________________________________________________

Date: _______________________________________________________________________

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Appendix 1

Section 4

CONFIDENTIALITY AGREEMENT
In consideration of your participation in the examination process that forms the basis for SCDM’s
Certified Clinical Data Manager Certification Program (“the Program”), and to set forth a clear
understanding of your obligations relating to the Program, you agree as follows:
(1) To preserve the integrity of the Program, you will maintain test questions and your knowledge of
the contents of and the subject matter addressed in those questions (“the Test Questions”), in
confidence and will refrain from disclosing or using them.
(2) Your obligation of nondisclosure does not apply to substantive information that was in your
possession prior to this agreement or which became public through no fault or omission on your part,
provided, however, that you may not disclose to others whether such substantive information is or is
not a part of the Program’s certification examination.
Your obligation of nondisclosure shall also not apply if you are required to disclose Test Questions in
connection with a legal or administrative proceeding, provided, however, that you agree to give the
SCDM Certification Committee chair prompt written notice of such a request.
(3) All intellectual property rights, including without limitation all copyright, are the sole and
exclusive property of SCDM. SCDM shall have the right to obtain and hold in its name rights of
copyright, copyright registrations and any similar protection.
(4) All nondisclosure obligations imposed by this agreement shall terminate ten (10) years from the
date of this agreement.
(5) You represent and warrant that you are empowered to enter into this agreement and to grant and
assign the rights granted and assigned herein to SCDM. You further represent and warrant that you
have not previously granted or assigned, in whole or in part, to any other person or entity, including
without limitation your employer, any of the rights granted or assigned herein to SCDM.
(6) This agreement shall be construed in accordance with the laws of the State of Wisconsin.

AGREED:
_____________________________________
Signature
________________________________________
Print Name
________________________________________
Date

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Appendix 1

Section 5

PAYMENT INFORMATION

Please include a check, money order or credit card number and expiration date for a NON-REFUNDABLE*
application fee $195.00. This fee must be paid in U.S. Dollars.

*In the event that your application is rejected, a portion of your application fee, less administrative and
handling costs, may be returned to you. Once the application is accepted, no refund will be granted.

Method of Payment:
□ VISA □MasterCard □AMEX □Check
Credit Card number: ___________________________Expiration date: _____/______

Name on card: _________________________________________________________

Signature: _____________________________________________________________

NOTE: Please contact Sue Abrahms at [email protected] if you would like to submit your exam
fee via a wire transfer.

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Appendix 2

Eligibility Requirements for the Certified Clinical Data Manager Examination

You do not need to be a member of the Society for Clinical Data Management (SCDM) to apply for or
take the examination to become a Certified Clinical Data Manager (CCDM®).

You do not need to be currently employed as a Clinical Data Manager (CDM) in order to apply for or
take the examination.

You do not have to have a college degree to be eligible to take the examination; however, you must
meet one of the following criteria:

• Bachelor’s degree or higher plus 2 or more years full time CDM experience

• Associate’s degree (2 years) plus 3 or more years full time CDM experience

• No degree plus 4 or more years full time CDM experience

• Part-time work experience will be translated into full time work experience

Anyone who has had his/her CDM certification currently suspended is not eligible to take the
certification examination until his or her suspension is completed.

Anyone whose name is on the FDA debarment list or has had his or her certification permanently
revoked is not eligible to take the certification examination.

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Appendix 3

Application for Certified Clinical Data Manager (CCDM®) Examination Retake

You may retake the exam within one (1) calendar year of the formal notification letter date of your original
exam results. After that, a full application must be submitted and the full fee structure applies.

The fee to retake CCDM® exam is $125.00.

Candidate Name:

Candidate ID: __________________________

Candidate Home Address:* _________________________________________________________

_________________________________________________________

Candidate Daytime Phone:* ________________________________________________________

Candidate E-mail: _______________________________________________________________

*Mandatory item your application will not be processed without this information.

Retake Fee: $125.00

Method of payment: (Make checks payable to: Society for Clinical Data Management)

Visa MasterCard American Express Check or Money Order enclosed

Note: Credit Card information is kept secure.

Credit Card number:

Expiration date: (month/year): /

Name on card (please print):

Signature: Date:

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Appendix 4

Submission Form

Name: ________________________________ SCDM ID# __________________

Use this form for professional development activities:

• IACET CEUs
• Webinars, conferences, forums, tutorials
• Listing of other SCDM involvement (committees, published articles, presentations)
• Non-SCDM educational activity

Number of Office
Evidence of
Title of Activity Completion Sponsoring Organization Contact Use
Attendance
Date Hours Only

Date: _________________________________ Email: _____________________

Contact Hours are actual time spent in the educational activity minus breaks
Evidence of Attendance can be a copy of a certificate or letter of completion/attendance.
1 contact hour = .1 CEU

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Appendix 5

Certification Renewal Application

Please type or print all information below, indicate responses where required, sign in the appropriate space and return
with the required enclosures to:

Society for Clinical Data Management, Inc.

555 East Wells Street
th
11 Floor, Suite 1100
Milwaukee, WI 53202

Section 1

First Name*______________________ Last Name*______________________ MI*___

(*Enter name, as it should appear on the certificate)

Company Name __________________________________________________________

Title _________________________________ Department ________________________

Mailing Address __________________________________________________________

City__________________________________State/Province______________________

Zip/Postal Code_____________________ Country___________________________

Work Phone________________________

Fax _______________________________

Email______________________________

Please include a current copy of your resume or CV, which should include updated education
and work experience since your last application.

CCDM®s certified after 2004, will need to accumulate 1.8 CEUs for CCDM® renewal or you may
choose to take the current CCDM® examination.

 I have acquired CEU's– Please submit the attached form listing accumulated CEUs.
If non-IACET CEUs were obtained, please complete the Non-IACET Affidavit Form

 I will take the CCDM® exam.

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Appendix 5

Section 2

Fee:

Renewal Application Fee:  $95

CCDM® Exam  $195

Method of  Visa  Mastercard  American  Check enclosed

payment: Express
Credit Card number: _________________________________________

Expiration date: ____________________________________________

Name on card: _____________________________________________

Signature: _________________________________________________

*
The renewal fee is NON-REFUNDABLE. In the event that your application is rejected, a portion of your application fee,
less administrative and handling costs, may be returned to you. Once the application is accepted, however, no refund will
be granted.

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Appendix 5

SECTION 3

AUTHORIZATION

I hereby authorize the Society for Clinical Data Management (SCDM) to make whatever inquiries it
deems necessary and appropriate to confirm the accuracy of the contents of my application. I agree to
provide any additional authorizations necessary to that process. I hereby authorize SCDM to use the
information contained in my application and/or examination for purposes of statistical analysis,
provided that my personal identifying information has first been deleted.

APPLICATION INFORMATION

I hereby certify that I have reviewed the information contained in this application and that it is
complete and truthful. I understand that my presenting false or incomplete information may be cause
for loss of eligibility to take the CCDM® examination, for denial of my application for re-certification
or for revocation of any certification granted.

EXAMINATION

I understand that I may be disqualified from taking or completing the CCDM® examination or from
receiving examination scores if SCDM determines through proctor observation or otherwise that I
engaged in inappropriate behavior during the examination.

CLINICAL DATA MANAGEMENT ACTIVITY

I hereby represent and warrant that I have at all times acted in compliance with the SCDM Code of
Ethics and with those laws and regulations applicable to clinical research, including without limitation,
the Declaration of Helsinki and applicable U.S. Food and Drug Administration regulations. I
understand that conduct at all times in violation of the spirit of the Code of Ethics or applicable laws
makes me ineligible to take the certification examination and can be cause for permanent revocation of
my certification status.

TERMS AND CONDITIONS OF USE OF THE CCDM CERTIFICATION MARK

I hereby agree that, should I become a re-certified professional, I will abide and be governed by the
Terms and Conditions of Use of CCDM® Certification Mark, a copy of which has been provided to
me.

Candidate’s signature ____________________________________

Date ______________________
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Appendix 6

Competency Domains Addressed in CCDM® Exam

Section 1
Project Management – Scope, Definition and Management
Project Management – Process Design, Management and Documentation
Project Management – Project Communications
EDC
Overall Clinical Trials Process, Roles & Responsibilities
Protocol Review
Data Management Plans
Clinical Database Design/Relational Databases
CRF Design

Section 2
Processing Lab Data
Maintenance of Lab Normal Range Information
CRF Tracking
Communication of Data Trends
Query Resolution
Query Tracking
CRF Data Entry Process – Discrepancy Resolution
CRF Data Validation (e.g. data review, cleaning, query generation, applying data handling
conventions)
Database Updates

Section 3
SAE Reconciliation/Safety Review
Coding (AEs; Signs and Symptoms)
Coding Medication
Database Quality Control Audits
Database Lock Procedures
Application of Randomization Schemes (Breaking the Blind)

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Appendix 7

CEU & Participation Credit Percentage Chart

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Appendix 8

Non-IACET CEU Affidavit Form

For non-SCDM educational offerings, applicant must sign affidavit below and include all course
materials, brochure and/or advertisement of course as well as a corroborating reference signature.

Affidavit Requirement

I _____________________________verify under penalty of revocation, that I successfully

completed the course titled _____________________________

offered by (Institution)_____________________________

on the dates of _____________________________

Duration of course* ______________

Participant Signature_____________________________ Date ________________

Reference Signature _____________________________ Date ________________

* excludes break and meal times

Attachments required for approval

1. Printed description and details provided by the educator

2. Speaker information (Bio/Curriculum Vitae)
3. Attendance Verification (A Certificate of Completion is the only verification acceptable)

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