A Professional aCRF Designing With Multiple Studies

Duration: 30 Days
Level: Advanced
Prerequisite: SDTM
Fast-Track: Available
Fast-Track Duration: 15 Days

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In aCRF Designing: An Annotated Case Report Form (aCRF) is a PDF document that maps the study data collected in CRF fields to the corresponding variables in the SDTM datasets.

Why aCRF Is Necessary: A good way to understand the study and database ü From the perspective of reviewers, can know the CRF page source of the variables in SDTM when review SDTM define.xml, also can know how the information in every field of CRF map into SDTM database when review aCRF, then get a whole and clear recognition of the study and database quickly.

Standardization CRF & aCRF :The standard CRF is designed based on CDISC standard, make sure one page in CRF can display one domain or one category of domain information as much as possible. q In a new study, we can refer the standard CRF to design CRF, extract the proper pages, modify and add some specific pages according to requirement.

In the training you will be learning with different documents

1) Rawdatasets
2) Blank CRF
3) SDTM Control Terminology
4) Protocol
5) Blank Annotated aCRF
6) SDTM IG Guide
7) CDISC Annotation Rules.
8.Finally SDTM annotated aCRF will be desigined

Final Overview: In this aCRF you will be learning on 2 studies.

1. Simple
2. Advanced in an experience Level.
3.With all the supportive documents we will be explaining the real-time flow .

In this Course You will be primarily focus on these domains :

1. Demographic
2. Inclusion criteria
3. Exclusion Criteria
4. Disposition
5. Medical History
6. Oncology Domains
7. Physical Examination
8. Vital sign
9. Cardio vascular
10. Electro Cardio Gram
11. Laboratory
12. Exposure
13. Questionaire
14. Death details
15. Adverse events
16. Hospitalization
17. Drug Accountability and few more…

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