Guide To Career In CDM

Question 1

What is Clinical Data Management?

Answer 1

It is a process which leads to generation of high quality, reliable, and statistically sound data from clinical trials

It ensures collection, integration and availability of data at appropriate quality and cost

Question 2

Objectives of Clinical Data Management

Answer 2

Data collection - paper, electronic and/or remote data capture

Data integration - Integration data from all sources in a single database.
It ensures consistency and correctness

Data validation - Validation done via user acceptance testing (EDC system fulfills the requirement of the study)
and Quality Control

Question 3

Roles and responsibilities of CDM (6)

Answer 3

1. To provide consistent, accurate and valid clinical data
2. Integrity of clinical trials data is the core purpose of CDM
3. Ensures clinical projects deliverables that are timely and requirement compliant
4. The trail database is complete, accurate and true representation of what took place in the trial
5. The trail database is sufficiently clean to support statistical analysis and its subsequent presentation and interpretation
6. To support the accuracy of the final and conclusion reports

Question 4

Common databases (6)

Answer 4

Oracle Clinical
Medicate Rave
Inform
Veela
IBM Clinical Development
MedRIO

Question 5

Stages/phases of Clinical trial where CDM is present

Answer 5

1. Study startup
2. Study conduct
3. Study closeout

Question 6

Start-up phase

Answer 6

1. Protocol review
2. Design an finalise (db, crf, ccg, dmp, dvs, dta and dts )
3. Testing (qc, uat, ist )
4. Database goes live

Question 7

Conduct phase(6)

Answer 7

1. Data entry
2. Medical Coding
3. Data Cleaning
4. Resolution and update database
5. Quality Control
6. Ready for freeze and lock

Question 8

Data Entry (5)

Answer 8

1. Direct capture (by site staff to the EDCs)
2. Non CRF (from sponsor, inside labs etc)
3. Devices and apps (by non site personnel)
4. Electronic and Health record System
5. Safety Database (collection of Adverse Events)

Question 9

Data Cleaning (5)
Process 1->2->3 (…)

Answer 9

1. Data review
2. Discrepancy management
3. Query generation
4. Lab reconciliation
5. SAE reconciliation

CDM sees an error/inconsistency -> rise a query to the site if data is correct(to the clinical trial coordinator) -> resolve an query/amandement ->lab reconciliation -> SAE reconciliation(clinical db and safety db[Argus most commonly])

Unresolved questions goes to the DM issue log

Everything simultaneously for years of the study

Question 10

Close-out phase (6)

Answer 10

1. Freeze
2. Pre-lock checklist
3. Hard lock
4. Biostats
5. Case Study Report (Medical Writer)
6. Regulatory Authorities

Question 11

Pre-lock Checklist (6)

Answer 11

1. Data review
2. Review Coding
3. Check SAE
4. Query Status
5. SDV(source data verification) by CRA(clinical research associate/monitor)
6. Signatures
   
   • CDM
   • MDR
   • Coder
   • PI
   • Sponsor

Question 12

Summary of Phases (12)

Answer 12

1. Protocol design
2. CRF design
3. Metadata design
4. Database design
5. Database validation
6. Data collection
7. Data entry
8. Data cleaning
9. Dataset locked
10. Statistical analysis
11. Report writing
12. Send to regulatory authorities

Question 13

Clinical trials phases

Answer 13

Phase I
Healthy volunteers
Small(eg 20),short
Focus on safety and begin to identify an appropriate dosing
Investigates pharmacokinetics, how the drug act in human metabolism

Phase II
Target population
Larger and longer
Focus on showing the effectiveness of treatment and determining appropriate dose, and gather more safety informations
Blinded

Phase III
Target population
Larger longer
To show effectiveness and assess benefit to risk profile with respect to side effects
Randomised and blinded