All Adverse Events and Previous/Concomitant Medication should be coded and/or approved prior and during the trial.
Before adverse event terms can be reported or analyzed, they must be grouped based on their similarities. For example, headache, mild headache and acute head should all be counted as the same kind of event. This is done by matching (or coding) the reported adverse events against a large codelist of adverse events which is also known as dictionary or thesaurus.
Test cases and other documentation associated with the testing of auto-coding should be produced/documented. This documentation is not part of the plan. It is a product of the design process and should be filed separately in the TMF system.
In the DMP. you should document the variables and the dictionary to be used.
For Concomitant Medications, WHO drug reference list is used. Also document the version used and if applicable, the final version of the who drug (for trials running over 6 months).
For Adverse event, MedDRA dictionary is the choice of coding method. Document the version used.
Serious Adverse Event (SAE) Reconciliation:
Indicate SAE Reconciling Approach to be used to compare SAE database (e.g. Argus) to the Clinical study| database (e.g. EDC):
- Indicate tools to be used
- Location of SAE data
- Planned timing
- Planned frequency of SAE Reconciliation activities
What to look for during reconciliation:
- There are matched cases but minor differences such as onset date
- Case found in the CDMS but not in the SAE system
- Case found in the SAE system but not in the CDM system
Methods for Reconciliation:
For electronic-automatic reconciliation between systems, there are some challenges you need to identify first such as which type of data is to be reconciled and then which fields to compare. Best practice is to reconciled those considered serious according to regulatory definitions.
For manual reconciliation, reports such as SAS listings extracted from both systems with study information, subject or investigator and other key data can be used to perform manual review. A manual comparison of the events can then assure that they are both complete and comparable.
No matter which method you used for reconciliation, each type of data (eg, AE, MedHist, Conmed) should document which glossaries and version were used.
DIA -A Model Data Management Plan StandardOperating Procedure: Results From
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Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, Medrio, IBM eCOS, OpenClinica Open Source and Oracle Clinical.