Data Management in

Clinical Trials

E-CRF design / P-CRF

Data entry Data validation

Data import

Clinical coding

DATABASE CLOSURE

Database Closure

Documents

Database lock

Tables & listings /graphs

SAS programming finalising analysis

database

Draft report

Final report

Databaseexport

Protocol

Monitoring

Data Management

Plan

Data Management Plan, DMP

The DMP is a description of data management activities for capturing and validating data during a study.

Included in DMP1. List of abbreviations

2. Definitions/Clarifications

3. Introduction

4. Study information/Description

5. Data Management System (CDMS)

6. Data management procedures

7. Data entry procedures

8. Data query handling

9. Data validation procedures

10. Coding procedures

11. Database closure

12. Export of data

13. Import of data

14. Appendix

CRF

• CDISC/CDASH standard or sponsors standard (should be stated in the contract).

• Footnote on all pages containing: version, date and initials

• Header on all pages containing: study number, site number, subject number, subject initials/ID, visit number.

• Follow ICH GCP guidelines.

• Follow GCDMP guidelines.

P-CRF (paper CRF)

P-CRF

• Reviewed by internal study team (PM, DM, STAT, monitor) before sent to sponsor

• Reviewed by clinical team (sponsor, investigator, study nurse)

• Approved by sponsor (if required by sponsor), PM, DM and STAT (date and signature)

• Remember CRF Receipt Log when using P-CRF

E-CRF (Electronic CRF)

E-CRF

• Created in CDMS

• Reviewed by internal study team (PM, DM, STAT, monitor)

• Reviewed by clinical team (sponsor, investigator, study nurse), review = access to a test database

• Approved by sponsor (if required by sponsor), PM, DM and STAT (date and signature)

DATA ENTRY (DE)

• At site (E-CRF)

• Internal (P-CRF)

• Single or Double DE

• Data Entry Log

• Data Entry Problem Sheet (DEPS)

• Data Handling Instructions• E.g. Enter date as YYYY-MM-DD• E.g. Enter Not Applicable as NA

QUERY HANDLINGP-CRF

• Data entry errors documented in DEPS (Data Entry Problem Sheet). DM investigates whether these errors should be queries/DCF.

• CDM can also produce queries from logical checks.

• During QC. 

 

QUERY HANDLING

E-CRF

• Query handling in the system according to the E-CRF

• Queries can be generated by monitor or DM within (or outside) the system.

• Logical checks can be included in the CDMS or be created outside the system.

QUERY HANDLING

All CDM queries are logged (study number, site, subject

number, date sent, name of query creator, date

received, date when changed in DB in paper CRF, name of person who changed query in DB)

CLINICAL CODING

Clinical Coding – the translation of medical terminology into a standardized coded format that is recognized nationally and internationally.

CLINICAL CODING

• Study specific coding information in the DMP, e.g. what to code, dictionaries, when coding is to be done.

• Coding done by assigned coder.

• Reviewed and confirmed by medical reviewer.

• Final coding approved (signed and dated) by sponsor.

• Final coding dictionaries version should be documentet

• If all been coded or something is uncoded medication/AE/Med hist documented in the DHR (Data Handling Report)

DATA IMPORT/EXPORT

• According to specification in DMP

E.g. ECG, biomarkers

• Validation of imported/exported data

Transfer specification

DATABASE CLOSURE

• When all queries are solved:• Quality Control

• Proof Reading (only P-CRF)• Logical Checks

• Approved Clinical Coding

• Approved Statistical Analysis Plan (SAP)

• All issues are documented

• Approved and signed Database Closure Document