CDM

Question 1

CLINICAL TRIAL

Answer 1

Clinical trial is an observatory study for Drug Biologicor a Device for its pharmecokinetic and Pharmecodynamic properties and also the adverse events caused by the investigational product on the subject.

Question 2

PHASES

Answer 2

Phase 1: Safety
Phase 2 : Exploratory
Phase 3: Therapeutic confirmatory
Phase 4: Post Marketing Trial

Question 3

IND

Answer 3

Investigational New Drug, approval got from FDA after Non-Clinical Trial. It is necessary to get approval from FDA before testing on humans.

Question 4

NDA

Answer 4

New Drug Application , approval got from FDA after trial 3 and before trial 4 before marketing the drug.

Question 5

Trial Master File

Answer 5

The Trial Master File refers to a repository of documents that collectively can be used by monitors, auditors, assessors and sponsors to demonstrate that a clinical trial has been conducted in compliance with Good Clinical Practice (GCP) and the approved protocol.

Question 6

CRF

Answer 6

CRF stands for case report/record form. CRF is the most important document after the protocol since all the clinical trial data is collected through the CRF.

Question 7

Approved Consent

Answer 7

It is an agreement between the volunteer and the CRO with the consent to undergo the trial process. In case of children it is called assent.

Question 8

21 CFR Part 11

Answer 8

Verification of electronic signatures

Question 9

Study Build

Answer 9

Protocol Approval 
Design CRF
Database Design 
CRF Completion Guidelines 
Edit Check 
UAT 
Data Management Plan
Data Validation Plan

Question 10

Study Conduct

Answer 10

Query Generation
Discrepancy Management
SAE reconciliation

Question 11

Audit Trail

Answer 11

Timestamp based record to keep a track of changes in the database.

Question 12

SAE reconciliation

Answer 12

Comparison of the two databases (clinical and Safety )Occurs multiple times based on the frequency of the data entered and the updation of safety guidelines
Ensures
Key safety data in same format and data fields are the same and also same codelist for the field when applicable

Question 13

Study Closeout

Answer 13

Ensure QCs are resolved
„ All AEs are properly followed at study exit
„ All participant documentation is up to date
and well organized
„ Shipment of samples in a timely manner
„ IRB submissions for continuing review until
all study data has been locked
All the Source Data Verification is complete.
All the medical coding terms are consistent
All the Adverse events are recorded and reconciled.

Question 14

Annotated CRF

Answer 14

Annotated CRF is a blank CRF (Case report form) in which variable names are written next the spaces provided to the investigator. Annotated CRF serves as a link between the raw data and the questions on the CRF. It is a valuable tool for the programmers and statisticians.

Question 15

DMP

Answer 15

DMP document is a road map to handle the data under foreseeable circumstances and describes the CDM activities to be followed in the trial.
Contains Data Handeling process, Quality Control, Data transfer format.
It contains details about how the data is going to be handeled in the clinical trial. Right from the study overvirew, dictionary or coding data, CRF completion guidelines, Data storage and archival, Data validation Plan, Quality Control,Access permissions.

Question 16

Hard and Soft locks

Answer 16

Hard lock: accessible to no one, equivalent to freeze

Soft lock : accessible in read only format to higher authorities

Question 17

Data Transfer Specification

Answer 17

Legal agreement between the sponsor and CRO to ship all samples with a specific format. It contains information like subject #, initial phase, visit #, Scheduled or unscheduled visit, the format of the number they place in the corresponding sample.Key Components are Format,frequency,method of transfer, variable specification,blinding requirements,data reconciliation process.

Question 18

Sections of protocol that are important to the CDM

Answer 18

Time and Schedule events, primary secondary and exploratory objective, study procedure and study design.

Question 19

Key fields to be reconciled in SAE

Answer 19

Subject ID 
SAE verbatim 
LLT 
PT 
Onset date 
end date 
severity level 
system organ class 
severity category 
Action taken

Question 20

5 categories of seriousness criteria

Answer 20

Death 
Birth defect 
hospitalization
permanent damage 
life threatening

Question 21

SLA (Service Level Agreement)

Answer 21

Description of what the service provider will do
Quality and timing of service
How performance will be monitored
How problems will be addressed

Question 22

KPI ( Key Performance Indicator)

Answer 22

A Key Performance Indicator (KPI) is a measurable value that demonstrates how effectively a company is achieving key business objectives. Organizations use KPIs to evaluate their success at reaching targets. … Each department will use different KPI types to measure success based on specific business goals and targets.Examples include if the data entered seems to be more erroneous then there is a possibility that the application has some fault or the site people did not understand the CRF completion guidelines so they need to be improved.

Question 23

CDISC

Answer 23

CDISC- Clinical data interchange standards consortium. They have different data models, which define clinical data standards for pharmaceutical industry.
ensures uniformity and vendor neutrality
easier for approval process
Easier to standardize data

Question 24

CDASH

Answer 24

Clinical Data Acquisition Standard Harmonization. Useful in creating a CRF ,name and type of fields that can be used.

Question 25

SDTM

Answer 25

Standard Data table model used to create proper datasets for statistical analysis.
Contains Analysis Data Set, Tabulation Datasets,
Patient profile,Listing datasets.
Contains information like the demographics,ConMed,Adverse Events etc in a standard format that needs to be submitted to the FDA

Question 26

Data Validation Plan

Answer 26

Automatic or manual procedure to detect missing data,illogical data and also the data that conflict with the protocol.

Question 27

Source Documents

Answer 27

Clinical records
Patient history
lab reports
letter from the physician

Question 28

Substantial Protocol and Non-Substantial Protocol

Answer 28

Substantial Protocol : are those which affect the mental ,physical status of the patients. It involves change in quality or dosage in the clinical product under trial.
Non- Substantial Protocol: The administrative changes that do not impact the subject.

Question 29

Schedule for SAE

Answer 29

Sponsor to FDA in 14 days
Investigator to Sponsor - 24 hours
Investigator to Ethic committee - 7 days

Question 30

GCP Regulation

Answer 30

21 CFR 11: Electronic Records and Signature
21 CFR 50: Protection of human subject in Clinical Trial
21 CFR 54 : Financial disclosure
21 CFR 56 : IRB that oversees clinical trial
21 CFR 312 : INDA
21 CFR 314 : NDA
21 CFR 812 : Investigation device excemption
21 CFR 814: Premarket approval of the medical device

Question 31

Discrepancy Management Procedure

Answer 31

As a result of batch validation, the discrepancies that arise in the database are managed by the discrepancy management team.

a) Discrepancies are resolved through the data clarification form (DCF) or data query form (DQF).
b) DCF is generated and sent to site for clarification.
c) After the corrected values are received from the investigator as a response to the DCF, the responses are updated in the database.
d) After ensuring that the data is error free, the database is locked to avoid further unauthorized modification.

Question 32

Double Data Entry

Answer 32

Double data entry is the process of entering the same data twice in pass one and pass two, by two different individuals.
Double data entry is important because it helps in reducing the discrepancies that arise due to errors in data entry

Question 33

Father of Clinical Trial

Answer 33

James Lind

Question 34

EDC

Answer 34

software that stores data collected on a clinical trial from the patients. 
contains 
Graphical User Interface 
Validation tool 
Report tools

Question 35

Tell us about the domain datasets that you have used for a clinical trial

Answer 35

Medical Prescriptions, ECG,Lab Reports,Demography, Adverse Events ,vitals etc.

Question 36

Example of edit checks made in programs?

Answer 36

Demography: BMI is below expected but the weight is outside expected range.
DOB is greater than the visit date or not.
Gender value is valid or invalid
Age is between the expected range.

Question 37

CRM (Clinical Research Manager)

Answer 37

They supervise informed consent from the CT ,CRF design and writing of protocols. CRM ensures that CRF are reviewed and submitted to the Data Management group.

Question 38

Pharmecokinetic Parameter

Answer 38

What your body does to the drug. Basically absorption, distribution and excretion.