Introducing CDISC Standards Certification
To accommodate the high demand for professionals with proven experience implementing CDISC Standards and integrating our standards into an organization’s systems and processes, CDISC is now offering certification to individuals within the standards community with experience, a passing grade on the certification exam and annual certification maintenance.
CDISC Standards Certification is a benchmark of excellence which can be used to:
- Validate Skills
- Assess Potential Hires
- Provide Your Clients With Proven Expertise
- Fast-track Your Career
As an additional convenience, you have the option to take the test at an approved test center or from the convenience of your home or office.
Be Among the First to Attain Certification
CDISC Tabulate, based on knowledge of SDTM and the SDTMIG, is the first CDISC certification to demonstrate proficiency in tabulating clinical research data.
Registration for the Tabulate Certification Program will be available August 2021. Mark your calendar and check back for additional details.
Many thanks for those of you who participated in our pilot exam. You will receive your results as soon as your scores are calculated.
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
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.
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 exam duration is expected to last 3.5 - 4 hours.
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.
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.
If you wish to change your exam date or time, you must do so no later than 5 days prior to your appointment.
Yes, experience in any CDISC standard can be considered for the 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.
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.
You can find a testing center by selecting the Locate link on the Certification testing taker page.
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.
Yes. Please contact CDISC Certification for more information.
Exam Scope and Validity
No, the exam is version agnostic.
The certification is valid for three years You may retake the test after three years.
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.
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.
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.
CDISC will contact you six months before your certification is due to expire with instructions on registering for the Tabulate certification exam.
Review the sample CDISC Tabulate Exam questions and their corresponding Exam Domains below. The answer key for the practice test is located at the bottom of the page. You can review the Knowledge and Skill Statements associated with each Exam Domain by visiting the Tabulate Exam Scope page. Please note that the practice test questions do not appear in the Tabulate Exam.
Domain 1: General Concepts, Terms and Assumptions, and Conformant Dataset Structure
Which date/time determines the population of the EPOCH variable if included in a general observation class domain?
- Start date/time of an observation or collection date/time
- Reference time point date/time
- Disease milestone instance date/time
- Planned start or end of assessment interval, as appropriate
Domain 2: General Observation Classes
Which statement regarding topic or qualifier variables is correct?
- If CMTRT is not known for a record, it can be left empty.
- A value of "Dafalgan 10mg" in CMTRT is acceptable.
- CMDOSE and CMDOSTXT can both be populated in the same record.
- CMDECOD, if used, should contain a standardized medication/therapy term.
Domain 3: Domain-Specific Knowledge
Biomarker data pertaining to body temperature associated with a fever should reside in which SDTMIG domain?
- Biomarker Test Results (BR)
- Clinical Events (CE)
- Adverse Events (AE)
- Vital Signs (VS)
Domain 4: Findings About, Custom Domains, Associated Persons, and Study References
A custom domain should be established around
- A specific collection method.
- A specific set of timing criteria.
- Observations with a common topic that do not fit into an existing domain.
- An efficacy endpoint that fits well into an existing domain but should remain separate for analysis.
Domain 5: Special Purpose Domains
Why is the Demographics (DM) domain required for all human clinical trials regulatory submissions?
- It contains the actual order of elements followed by the subject.
- It is the parent domain for all other observations for human clinical subjects.
- It is a Findings domain that contains subject-related data not collected in other domains
- It is a Findings domain that contains general subject characteristics about demography.
Domain 6: Controlled Terminology, Conformance, and Other References
Which statement is correct regarding Therapeutic Area User Guides (TAUGs)?
- TAUGs replace or supersede foundational CDISC standards.
- TAUGs typically provide advice, examples, and explanations related to the use of foundational standards for a specific therapeutic area.
- Examples in TAUGs use only approved CDISC Controlled Terminology.
- A new SDTMIG domain introduced in a TAUG will be incorporated in the next release of the SDTMIG.
Domain 7: The Trial Design Model
Which statement about the Trial Inclusion/Exclusion Criteria (TI) domain is FALSE?
- The variable STUDYID is required in a TI domain.
- The variable USUBJID is not permitted in a TI domain.
- The TI domain is based on the Findings general observation class.
- The TI and IE (Inclusion/Exclusion Exceptions) domains use the same variables for test code (IETESTCD) and test name (IETEST).
Domain 8: Relationships Among Datasets and Records
Which statement is correct regarding the provided RELREC dataset?
- Row 1 and Row 2 show a one-to-one relationship between the CM and RS datasets.
- Row 1 and Row 4 show a one-to-many relationship between the CM and TU datasets.
- Row 2 and Row 3 show a many-to-many relationship between the RS and PR datasets.
- Row 3 and Row 4 show a one-to-many relationship between the PR and TU datasets.
Answers 1: A, 2: D, 3: D, 4: C, 5: B, 6: B, 7: C, 8: D