Clinical SAS : It includes the process that happens in Clinical Trial and various teams involved in this.
Sponser, person having an investigational drug/study drug contains protocol which includes each and every minute details about the clinical study.
Biostatistician– Based on protocol statistician prepares Statistical Analysis Plan(SAP) which contains the details of reports to be generated etc.
Investigator has Investigator Brochure(IB) that contains details or previous hx about drug, preclinical study details.
Clinical Data Management(CDM) team which includes data entry persons and data manager.
Data entry person – Enters the Data into CRFs(cAse Report Forms). These are of two types.Paper CRFs(where all the questionaries are mentioned in paper), eCRF(electronic CRF – Software will be installed in PCs and can directly enter data in the system).
Data Manager – Validates the data entered by data entry people and converts data into database tables. These database tables are later converted in datasets.
Pharmacovigilance team checks for the Serious Adverse Events.
SAS programmers generates the Reports based on the statistician requirements and submits to Biostatistician.Then Statistician will review and send comments to the SAS programmers.And approves the reports.
Medical writing people writes the synopsis to the reports and submits to Statistician who finally generates Clinical Study Report.
Data taken from subjects, Reports generated by SAS programmers and Clinical Study Report will be submitted to FDA. The data or reports submitted to FDA should be in CDISC standards.cubilia Curae; Vestibulum ligula libero, feugiat faucibus mattis eget, pulvinar et ligula.
CDISC SDTM & ADAM
CDISC : It includes SDTM/ADaM standards.
CDISC__Clinical Data Interchange Standard Consortium.
SDTM__Study Data Tabulation Model.
SDTMIG__Study Data Tabulation Model Implementation Guide.
- SDTMIG has been prepared by Submissions Data Standards(SDS) team of CDISC.
ADaM _ Analysis Data Model.
Training includes SDTM mapping, Creation of Analysis datasets and generating the Reports
Clinical Trial : It includes 4 phases. Before starting clinical trail, there will be Preclinical studies where study drug is tested in laboratories and on the animals.
Phase I – It includes 15-30 subjects.
Checks for Safety.
Phase II – It includes 100-200 subjects.
Checks for Efficacy.
Most of the clinical trials fails in this phase.
Phase III – It invoves 1000s of subjects.
Confirms the findings in large population.
More chances to detect rare side effects as large population is involved.
Then it goes for FDA approval.
Phase IV – It happens after approval.This simply called as Post-
Checks for more side effects and drug safety.
Checks for risks and benefits.
Done in real life patients(outside the clinical Trial site).