Implementation Strategies for CDISC SDTM Standards in Clinical Trials

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Welcome to this week’s episode of Dr. Clinidata! Hope your week was epic! 🚀

CDISC (Clinical Data Interchange Standards Consortium) is a non-profit organization that creates standards for clinical data collection, analysis, and exchange. These free standards are used by researchers, pharmaceutical and biotech companies, regulatory agencies, and technology vendors to enhance clinical research and global health through improved data accessibility, interoperability, and reusability.

Today, we'll explore strategies for implementing SDTM.

Adopting the CDISC SDTM standard in clinical trials can be streamlined through three specific implementation strategies: retrospective mapping, parallel strategy, and prospective mapping.

Retrospective Mapping is primarily suitable for older studies where creating a standardized data pool is essential. This method, while complex and time-consuming, is beneficial for building upon current and planned studies. However, it is prone to data interpretation issues due to the historical nature of the data.

Parallel Mapping offers better documentation, facilitating accurate mapping from original source data to SDTM. Despite its advantages, this method requires the submission of original source data to regulatory authorities since the analysis datasets are not derived from SDTM domains.

Prospective Mapping is the ideal approach, ensuring a logical and linear flow of data. This method eliminates the need to submit original source data, streamlining the regulatory process. Although initially time-consuming and challenging, this strategy enhances efficiency and confidence as procedures evolve and the industry standard becomes more solidified.

These strategies highlight the evolving procedures and growing efficiency in adopting the CDISC SDTM standard, ultimately benefiting the clinical trial industry through improved data consistency and regulatory compliance.

Phases of Clinical Trial

1. Phase 1:

• Objective: Assess safety and dosage.

• Participants: Small group (20-100 healthy volunteers or people with the disease).

• Focus: Determine safe dosage range and identify side effects.

2. Phase 2:

• Objective: Evaluate efficacy and side effects.

• Participants: Larger group (100-300 patients with the disease).

• Focus: Further assess safety and efficacy.

3. Phase 3:

• Objective: Confirm effectiveness, monitor side effects, compare with standard treatments.

• Participants: Large group (1,000-3,000 patients).

• Focus: Gather comprehensive data on effectiveness and safety.

4. Phase 4:

• Objective: Post-marketing surveillance to gather additional information.

• Participants: General population after the drug is approved.

• Focus: Long-term effects, optimal use, and further side effects.

In the following SAS program, the input data files are sorted by the NAMES variable:

libname prod 'SAS-data-library';
data prod.sales;
merge prod.sales work.receipt;
by names;
run;

Which one of the following results occurs when this program is submitted?

1. The program executes successfully, and a temporary SAS data set is created.

2. The program executes successfully, and a permanent SAS data set is created.

3. The program fails execution because the same SAS data set is referenced for both read and write operations.

4. The program fails execution because the SAS data sets on the MERGE statement are in two different libraries.

_{Reply me your answer}

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