CLINICAL DATA MANAGEMENT
ABOUT CISPACT TRAININGS
‘Cispact Trainings’ is an online education platform providing rigorous industry-relevant training programs designed and delivered in collaboration with world-class faculty and industry. Merging the latest technology, pedagogy, and services, Cispact is creating an immersive learning experience – anytime and anywhere.
We provide high-end professional education for aspiring and experienced professionals in Pharmaceutical and IT domains. Our hybrid platform delivers unique online experience that helps to build cutting-edge expertise, for today and tomorrow.
In Pharmaceutical sector, we provide trainings in Pharmacovigilance (Case Processing and Aggregate Report writing), Medical Writing, Management, Regulatory Affairs, Clinical Research Operations, Computer System Validation, Oracle Argus Configuration and Administrator, Clinical SAS (Base and Advanced) and Intellectual Property Rights.
- Drug Discovery, Development and Preclinical Studies
- Basics of Clinical Trials & Clinical Research
- Terminology & Definitions in Clinical Trials
- Types and Phases of Clinical Trials
- Good Clinical Practices (GCP) and Drug Recall
- Responsibilities of Clinical Research Professionals
- 21 CFR Part 11
- Protocol Orientation.
- Preparation of DMP/DHP.
- CRF Design.
- Preparation of DVP.
- CRF Annotation.
- DB-Design and Set-up.
- User acceptance test.
- Third party data specifications and testing.
- Coding Specifications and testing.
- SAE Reconciliation specifications.
- Self-Evident Correction specifications.
- Custom reports specifications.
- Tracking CRF Data.
- Data Entry, Remote Data Entry.
- Data review and query management.
- Managing Lab Data.
- Medical Coding.
- SAE Reconciliation.
- Post-Production Change management (PPC).
- Self-Evident Correction Management (SEC).
- Creating Reports.
- DB listings QC as per QC plan.
- Track all data as per DB Lock checklist.
- Final DB QC.
- Data Base Lock.
- Data Base archival and study data transfer.
- Case Studies
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