CDM Flashcards
CLINICAL TRIAL
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.
PHASES
Phase 1: Safety
Phase 2 : Exploratory
Phase 3: Therapeutic confirmatory
Phase 4: Post Marketing Trial
IND
Investigational New Drug, approval got from FDA after Non-Clinical Trial. It is necessary to get approval from FDA before testing on humans.
NDA
New Drug Application , approval got from FDA after trial 3 and before trial 4 before marketing the drug.
Trial Master File
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.
CRF
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.
Approved Consent
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.
21 CFR Part 11
Verification of electronic signatures
Study Build
Protocol Approval Design CRF Database Design CRF Completion Guidelines Edit Check UAT Data Management Plan Data Validation Plan
Study Conduct
Query Generation
Discrepancy Management
SAE reconciliation
Audit Trail
Timestamp based record to keep a track of changes in the database.
SAE reconciliation
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
Study Closeout
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.
Annotated CRF
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.
DMP
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.
Hard and Soft locks
Hard lock: accessible to no one, equivalent to freeze
Soft lock : accessible in read only format to higher authorities
Data Transfer Specification
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.
Sections of protocol that are important to the CDM
Time and Schedule events, primary secondary and exploratory objective, study procedure and study design.
Key fields to be reconciled in SAE
Subject ID SAE verbatim LLT PT Onset date end date severity level system organ class severity category Action taken
5 categories of seriousness criteria
Death Birth defect hospitalization permanent damage life threatening
SLA (Service Level Agreement)
Description of what the service provider will do
Quality and timing of service
How performance will be monitored
How problems will be addressed
KPI ( Key Performance Indicator)
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.
CDISC
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
CDASH
Clinical Data Acquisition Standard Harmonization. Useful in creating a CRF ,name and type of fields that can be used.
