Steps to Clinical trials Overview

o SOP are prepared.

o Data management plan (Clinical data management system, Description of data sources,
Data handling processes, data transfer formats, quality control procedures)
o Case Report form designs

Case report form (CRF) to collect data from each participating patient.

o Data design and built

Entry of data from CRF into database.

o Computerized system validation

Trial validation before main trials

o Validation Rules

Ensure completeness and consistency of clinical trials

o Data queries

When validation rule is not passed.

Errors are to be resolved.

o Central Laboratory data

Samples collected during a clinical trial sent to laboratory for analysis.

Data processed in CRF

o Other external data

Analysis of clinical trial data may be carried out by laboratories, image processing specialists or
other third parties.

Data is reconciled in CRF

o Serious adverse events

CRF collects adverse effects reporting’s during clinical trials.

o Patient recorded data

Record data like daily symptoms.

Patient diaries are prepared in electronic format.

o Data finalization and extraction

Database finalized when all expected data is accounted, all queries closed, all external data
received and reconciled.

International Network of Clinical Data Management Associations (INCDMA)

Association for Clinical Data Management (ACDM) is a global organization