CDISC Compliance Assessment Questionnaire Form
CDISC Compliance Assessment Questionnaire Form — assess your organization’s processes and practices for alignment with applicable CDISC standards.
Respondent name
*
First Name
Last Name
Organization name
*
Work email
*
example@example.com
Which CDISC standards are relevant to your organization’s work?
*
SDTM
ADaM
CDASH
SEND
Define-XML
Not currently sure
Other CDISC standards or models
What best describes the study scope covered by your current processes?
*
Clinical trials
Nonclinical studies
Both clinical and nonclinical studies
No current study scope
Other or varies by project
How would you rate your organization’s overall implementation of applicable CDISC standards?
*
Not implemented
1
2
3
4
Fully implemented
5
1 is Not implemented, 5 is Fully implemented
How consistently are these practices established across applicable studies?
*
Rows
Not established
Partially established
Mostly established
Consistently established
Not applicable / unsure
Standards implementation procedures are documented
1
2
3
4
5
Study data and metadata are reviewed against applicable standards
6
7
8
9
10
Validation checks are performed and results reviewed
11
12
13
14
15
Documentation and traceability are maintained for validation findings
16
17
18
19
20
What are the most significant gaps or challenges in aligning your processes with applicable CDISC standards?
Which follow-up priorities would be most useful?
Training and staff guidance
Process or procedure updates
Validation and quality review improvements
Documentation and traceability improvements
Standards applicability review
Other priority
Submit assessment
Should be Empty: