CRP 109 Lecture 1

Question 1

Clinical Research Data Management Overview

Answer 1

-biostats and medical writing (protocol development)
-database design (protocol review, data collection forms)
-Study activation (regulatory approval, site activation)
-clinical data documentation (site data collection)
-clinical data management (CRF data entry and SDV)
-Biostats and study report (data extraction and statistical analysis)

Question 2

Clinical Data Management

Answer 2

• Process generates high-quality, reliable, and statistically sound
  data from clinical trials
  -database design, data collection and entry, data validation, discrepancy management, medical coding, database locking and data extraction
  -Electronic records must comply with FDA 21 CFR Part 11 (USA)
  and Food and Drugs Act (Canada)
   Reduces time between drug development to marketing

Question 3

Most critical step in data management process

Answer 3

Discrepancy Management
 Query resolution and data clean up

Question 4

EDC Advantages

Answer 4

Benefits:
 Cost-effective
 Faster
 Bypassing processes of manual sourcing, transcribing, and
double data entry
 Enhanced compatibility
 Minimization of manual errors
 Data trends found more quickly
 Facilitates data collection to
improve data quality – check
boxes, drop down lists, etc.

Question 5

Vendor Selection & Management

Answer 5

 Sponsor’s responsibility for the quality and integrity of the
research data (ICH GCP)
 Define a detailed statement of work that delineates who is
responsible for each task: database design and build, project
reporting, processes, services, user training, study closeout, etc.
 Data hosting: stored on in-house servers, or outsourced to
vendor network

Question 6

Personal data

Answer 6

 Personal data – information that can lead to direct or indirect
identification of a research subject (e.g. subject name, initials, address,
genetic information)
 Relates to an individual’s body, personal information, expressed
thoughts and opinions, personal communications with others, and
spaces they occupy
-privacy Guaranteed to research participants via:
 REB-approved protocol
 Informed consent
 Right to withdraw consent
 Right to notice of disclosure
 Confidential collection and submission of data

Question 7

Consent

Answer 7

the right to exercise control over personal information
by consenting to, or withholding consent for, the collection, use
and/or disclosure of information

Question 8

Protecting Privacy as Researchers

Answer 8

 Protect from unauthorized access, use, disclosure, modification,
loss or theft of information
 Determine if information proposed for use is identifiable vs. non-
identifiable
 Consult REB if uncertain about whether information intended for
collection is identifiable
 Review data management processes regularly to ensure
consistency with regulations and company policies

Question 9

Protecting Privacy as Researchers continued

Answer 9

• Be mindful of restricting access to data in key areas (vendors, labs, etc)
• Provide privacy training to personnel who handle identifiable
  personal data
• SOPs on data privacy and data transfer between sites
• Design data-collection instruments with minimal subject identifiers
• Maintain appropriate physical and electronic security measures
• Protect information by redaction (anonymizing/de-identification)
• Implications of revealing a participant’s personal info?
• Embarrassment, loss of insurance coverage, or discrimination
  in the workplace

Question 10

When is a DSMB needed?

Answer 10

-large, randomized multisite studies that evaluate
treatments intended to prolong life or reduce risk of a major
adverse health outcome
-not required, but is recommended
-Does not alter responsibility of researchers or REB

Question 11

DSMB membership

Answer 11

 Independent group of 3-7 members (biostatisticians, clinical
disease experts, investigators)
 Ad-hoc members can be invited when additional expertise is required

Question 12

DSMB key responsibilities

Answer 12

 Periodically review accumulated study data for participant safety
and study conduct
 Make recommendations concerning the continuation, modification
or termination of the trial
 Modify protocol based on safety data
 Suspend or terminate study due to serious safety concerns
 Corrective actions for an underperforming site

Question 13

DSMB conflict of interest

Answer 13

 No direct involvement in the study
 No financial, proprietary, professional, or other interest in the
study that may affect decision-making

Question 14

DSMB charter

Answer 14

 Written document that outlines the composition and operations
of the DSMB, and its relationship to other stakeholders
 Membership requirements
 Meeting schedule and format
 Confidentiality requirements
 Criteria for assessing study data and making recommendations

Question 15

DSMB meetings

Answer 15

 Frequency:
 Before the start of the trial
 Regular intervals (minimum of once per year)
 Final recommendations are voted on by members

Question 16

DSMB tools

Answer 16

 Uses study-specific data and relevant background knowledge
about the disease, test agent, or patient population under study
 Study-related adverse events
 Rate of ineligibility determined after randomization
 Rate of participant withdrawal of consent
 Efficacy data
 Data completeness and timeliness
 Site performance and enrollment data
 Protocol deviations
 Factors that may affect study outcome