CDISC Standards Certification

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CDISC Standards Certification

CDISC Certification is a benchmark of excellence for demonstrating expertise in SDTM, a required standard for data submission to US FDA and Japan PMDA.

Organizations

  • Assess Potential Hires
  • Validate Experienced Candidates
  • Expedite Recruitment Efforts
  • Provide Clients with Proven Expertise
  • Reduce Training Time and Expenses

Individuals

  • Validate Deep SDTM Knowledge and Skillset
  • Demonstrate Professional Credibility
  • Advance Your Career
  • Increase Earning Potential
  • Streamline Your Job Search

 

Certification Register Now

 

Test Delivery

Take the test at an approved test center or from the convenience of your home or office.

 

Certification Maintenance

CDISC Tabulate Certification is valid for three years. To extend your certification you must retake and pass the exam in the six-month period prior to your certification expiration date.

 

Showcase Certification with a Digital Badge

CDISC will provide successful candidates with an exclusive digital badge to display in email signatures, social media profiles and CVs.

 

CDISC Standards Certification Exam Scope


Certification Requirements

To obtain the CDISC Tabulate Certification you must meet the following requirements:

  • Register for the certification and pay the corresponding fee
  • Pass the CDISC Tabulate Certification Exam

Your CDISC Tabulate Certification is valid for three years. To extend your certification you must retake and pass the exam in the six-month period prior to your certification expiration date.

 

Exam Composition

Passing the CDISC Tabulate Certification Exam demonstrates that you have attained knowledge and the competency necessary to utilize the SDTM and the SDTMIG.
The CDISC Tabulate Certification Exam consists of 125 questions. The average exam duration is 3.5 - 4 hours.

 

Exam Scope

Exam Domains
and Corresponding Weight
Knowledge and Skill Statements
General Concepts, Terms and Assumptions, and Conformant Dataset Structure (30%) Knowledge of the five major SDTM variable role types: identifier, topic, timing, qualifier, and rule
Knowledge of variables and their usage restrictions (e.g., variables not for use in human clinical trials, domain-specific prohibitions of variables, domain-specific variables)
Knowledge of the multiple uses of the two-character domain code
Knowledge of dataset naming conventions
Skill to correctly use the EPOCH variable
Skill in ordering variables correctly for the general observation classes (e.g., identifier variables, then topic variable, then qualifier variables, then timing variables)
Knowledge of the three values of the Core column: required, expected, and permissible
Knowledge of the rules for splitting domains into separate datasets
Knowledge of the use of metadata to describe the origin of variables or records in Define-XML
Knowledge of how to determine the natural keys for a dataset in which not all records have the same combination of variables defining a unique natural key
Skill to appropriately handle multiple values for a qualifier variable (e.g., race multiple) for result qualifiers and non-result qualifiers
Skill to appropriately handle multiple values for topic variables for events and interventions
Knowledge of the hierarchy of grouping variables and the scope of each grouping variable (e.g., for the subject, across subjects, and within subjects)
Skill to correctly apply formats for date/time variables, including the correct precision
Skill to correctly apply formats for duration and elapsed time variables
Knowledge of the algorithm for “study day” variables
Skill to appropriately use relative timing variables
Skill to appropriately use time point variables
Skill to appropriately use disease milestone timing variables
Skill to correctly represent original and standardized results
Skill to correctly represent options for indicating the fact that a test or set of tests was not done
Skill to correctly represent lengthy text strings
Knowledge of the of the Supplemental Qualifiers Name Codes appendix
Skill to correctly represent pre-specified interventions
Skill to correctly represent baseline values
Skill to identify the natural key structure of each dataset
Knowledge of the difference between a natural key and a surrogate key when identifying records and the use of the surrogate key --SEQ in SDTM
Knowledge of conformance with SDTM Domain Models, including metadata structure, domain names, variable names, data types, formatting, appropriate identifier and timing variables, and rules in assumptions and CDISC Notes
General Observation Classes (12%) Knowledge of the three general observation classes: interventions, events, and findings observation classes
Skill to accurately apply the SDTM requirements for the topic and qualifier variables in interventions observation class 
Knowledge of the standard domains of the interventions observation class (e.g., Procedure Agents, Concomitant/Prior Medications)
Skill to accurately apply the SDTM requirements for the topic and qualifier variables in the events observation class
Knowledge of the standard domains of the events observation class (e.g. Adverse Events,Clinical Events)
Skill to accurately apply the SDTM requirements for the topic and qualifier variables in the findings observation class
Knowledge that the findings observation class captures the observations resulting from evaluations to address specific tests or questions
Knowledge of the standard domains of the findings observation class (e.g.Tumor/Lesion Results, Vital Signs)
Knowledge of the required identifier variables (e.g., STUDYID, DOMAIN, and --SEQ), other identifier variables available in the SDTM, and their appropriate use in the three general observation classes
Knowledge of the availability of timing variables in the SDTM and the appropriate use of timing variables in the three general observation classes
Domain-Specific Knowledge (10%) Knowledge that the Pharmacokinetic Parameters (PP) domain represents results of analyses
Knowledge that pharmacodynamic data would not be represented in a custom domain of that name but in appropriate standard findings domains (e.g., response of blood pressure to dosing belongs in the Vital Signs (VS) domain)
Knowledge that biomarker data would not be represented in a custom domain of that name but in appropriate standard findings domains
Knowledge of the difference between representing dosing data in the Exposure as Collected (EC) domain versus Exposure (EX) domain
Knowledge that the units for Exposure (EX) domain are the protocol-specified units
Knowledge of the types of data that do and do not belong in Medical History (MH) domain (e.g., prior surgeries belong in the Procedures (PR) domain, not MH)
Skill to correctly construct the Disposition (DS) domain, including the correct use of DSCAT
Skill to appropriately use the DSTERM and DSDECOD variables
Findings About, Custom Domains, Associated Persons, and Study References (10%)
Knowledge of the requirements for the use of the --OBJ variable with Findings About events or interventions
Knowledge of when to use Findings About
Knowledge of the different references that would be needed when creating a new domain
Skill to create a custom domain
Skill to recognize data that are about an associated person rather than a study subject
Knowledge of considerations for creating an Associated Person (AP) dataset (e.g., family medical history, caregiver questionnaires)
Knowledge of the situations for which additional identifiers may be needed (e.g., identifiers for devices, identifiers for non-host organisms)
Knowledge of the Device Identifiers (DI) dataset used to establish identifiers for devices that are used to populate the variable SPDEVID
Knowledge of the Non-host Organism Identifiers (OI) dataset used to establish identifiers for organisms used to populate the variable NHOID
Special Purpose Domains (14%)
Knowledge of the appropriate use of special purpose domain datasets (e.g., Demographics [DM], Comments [CO], Subject Elements [SE])
Knowledge that the Demographics (DM) domain is required and which of its variables are required or expected
Skill to accurately create a Demographics (DM) dataset
Knowledge of the interaction between the Demographics domain (DM) variables and the Trial Arms (TA) dataset variables
Skill to accurately apply the SDTM requirements for representing comments in the Comments (CO) domain
Knowledge of the different ways of relating data in the Comments (CO) domain to data in other subject domains
Skill to accurately apply the SDTM requirements to create a Subject Elements (SE) dataset
Skill to accurately apply the SDTM requirements to create a Subject Visits (SV) dataset
Skill to accurately use the appropriate timing variables to represent planned and unplanned visits
Skill to accurately apply the SDTM requirements for representing the timing of disease milestones (defined by Trial Disease Milestones (TM) for each subject)
Controlled Terminology (8%)
Knowledge of the appropriate use of code lists, Controlled Terminology, and code list subsets (e.g., NY, STENRF)
Knowledge of CDISC Controlled Terminology Codetable mapping files
Knowledge of references to code lists (e.g., implementation guides)
Knowledge of the appropriate use of the new term request process
Knowledge of when sponsor code lists may be needed
Knowledge that the SDTM Controlled Terminology standards are versioned independently from the SDTM and SDTMIG
Knowledge of the existence of global supplemental conformance guides
Knowledge of the relationship between SDTM/SDTMIG and other CDISC standards and publications
Knowledge of the relationship between SDTM/SDTMIG and other dictionaries such as MedDRA and WHODrug
The Trial Design Model (10%)
Skill to create Trial Elements (TE) dataset for a straightforward randomized clinical trial
Knowledge of trial design concept definitions (e.g., epoch, arm, element)
Skill to create a Trial Arms (TA) dataset for a straightforward randomized clinical trial
Skill to create a Trial Visits (TV) dataset for a straightforward randomized clinical trial
Skill to create a Trial Inclusion/Exclusion Criteria (TI) dataset
Skill to create a Trial Summary (TS) dataset
Knowledge of considerations for creating Trial Disease Milestones (TM) dataset (e.g., protocol-defined events of special interest)
Relationships Among Datasets and Record (6%)
Skill to appropriately use the --GRPID variable to describe the relationship between a group of records for a given subject within the same dataset
Skill to create the RELREC special purpose dataset to describe relationships between records for a subject
Skill to create the RELREC special purpose dataset to describe relationships between datasets
Knowledge that RELREC should not contain assumed relationships
Knowledge of when it is appropriate to represent non-standard variables and their association to parent records as Supplemental Qualifiers (SUPP--) for SDTMIG-defined use cases

Register for CDISC Standards Certification

Demonstrate your proficiency in tabulating clinical research data.

Register Now

Exam Registration Discounts for CDISC Members: Platinum 40%, Gold 20%


Certification Program Details:

  • Exam fee: $500
  • Re-test fee (for those who do not pass on first attempt): $125
  • Fee not charged if exam is cancelled or rescheduled 30 days before exam date
  • A rescheduling/cancellation fee of $50 will be charged if requested more than 5 days, and less than 30 days, before the exam date
  • No refunds if an exam is canceled after 5 days prior to the exam date
  • Passing exam grade establishes certification for 3 years
  • Recertification required after 3 years
  • Recertification exam fee: $500
  • No annual maintenance fees
  • Group discounts available
  • Three years' experience working with CDISC standards is recommended to successfully complete the exam
  • Contact CDISC Certification for more information

 

Plan for your exam

 

Preparing for a Test Center Appointment

 

What to Bring to the Testing Center
You will be required to present a valid, government-issued photo ID with a signature (e.g., driver's license or passport). If you are testing outside of your country of citizenship, you must present a valid passport. If you are testing within your country of citizenship, you must present either a valid passport, driver's license, national ID or military ID. The identification document must be in Latin characters and contain your photograph and signature. All other personal items must be locked in a locker for test security purposes, so please limit what you bring to the testing center.

What Time to Arrive at the Testing Center
Plan to arrive 30 minutes before the scheduled appointment to allow time for check-in procedures. If you are late in arriving, you will not be allowed to test and will forfeit your exam fee.

 

Preparing for a Remotely Proctored Appointment

Prepare Your Environment
You must remove all personal items from the testing area except a surface to place your computer with a camera and microphone, a chair, the computer itself and your government issued photo identification.

What Time to Plan to Launch Your Exam
Be prepared to launch your remote exam 30 minutes before your scheduled appointment time to allow time for check-in procedures.

 

Reschedule/Cancel Policy

If you wish to change your exam date or time, you must do so no later than 5 days prior to your appointment.

Experience Recommendation

Does experience in CDISC standards other than SDTM count for the three-year experience recommendation?

Yes, experience in any CDISC standard can be considered for the experience recommendation.

Why is there a three-year experience recommendation?

We believe this is the minimum level of experience that test takers must have in order to have developed the specific skills that are tested on the certification exam.


Test locations

Can I take the test from my home or office?

Yes, test takers have the option to take the test remotely, provided their set up meets the remote proctor requirements, which can be found on the Prometric website.

 

How can I find out if there is a test center near me?

You can find a testing center by selecting the Locate link on the Certification testing taker page.

 


Fees

What is the cost?

A testing and admin fee of $500 is required for three years of certification. You will need to pay a retesting fee of $125 if you do not pass the exam. After passing the exam, you will be required to pay $500 and successfully pass the exam every three years to maintain your certification.

Are membership and group discounts available?

Yes. CDISC Platinum Members receive a 40% discount, Gold Members receive a 20% discount.  Please contact the CDISC Certification team for group discount information.


Exam Scope and Validity

Does the exam cover a specific version of the standard?

No, the exam is version agnostic.

How long is the certification valid for?

The certification is valid for three years You may retake the test after three years.


Exam Questions

Is there any specific training that is recommended to prepare for the Certification?

While there are no specific training courses for CDISC Certification, CDISC  does offer a variety of courses and webinars that may help you prepare for the exam.

How long will it take to complete the exam?

The average exam duration is 3.5 - 4 hours.


Other Certifications

Is CDISC planning to offer certification based on other CDISC standards?

Yes, we are looking at offering additional certifications based on other CDISC standards. If you haven't already, sign up for CDISC Communications to stay up to date.


Certified Individuals

How do I access my certificate and badge after successfully completing the exam?

Your certification and badge will be available on your CDISC learning system profile page. You can share the link to your public certification and badge page with others to verify their authenticity.

How will I know when I'm required to recertify?

CDISC will contact you six months before your certification is due to expire with instructions on registering for the Tabulate certification exam.

1) Split the SDTMIG  into six to eight manageable sections and commit to reviewing one section each week.  

2) Spread your study hours out over time (e.g., one hour every day or one to two hours every other day) rather than cramming in your exam preparation close to your test date. 

3) Create a schedule with regular intervals for study time and block out this uninterrupted hour on your calendar. 

4) For a one-hour study session, consider reviewing the last session’s material for 15 minutes and devoting 45 minutes to the new material. 

5) Use Quizlet.com to create free flashcards, or even create your own practice test questions to review with a colleague. 

6) Use the Knowledge and Skill Statements on the Exam Scope tab as a study review checklist.