2 Integrity

Question 1

IRB looks for when reviewing application

Answer 1

Risks to subjects are minimized
Risks are reasonable in relation to anticipated benefits
Selection of subjects is equitable
Informed consent will be documented appropriately
Adequate plans to appropriately monitor the data to ensure safety of subjects
Adequate plans to protect the privacy and confidentially of subjects
Vulnerable subjects rights and welfare are protected

Question 2

Purpose of Data Safety Monitoring

Answer 2

Identify safety problems, logistical problems, determine if trial objectives have been met and trial may be terminated early

Question 3

What does DSMB look at

Answer 3

Logistics- Enrollment, baseline data, protocol compliance, specimen, data quality
Adverse events
Interim variables
Response variables / endpoints

Question 4

Who makes up DSMB

Answer 4

Ethics Committee
Sponsor 
Regulatory Agencies
Investigators 
Safety Monitor

Question 5

Data Safety Monitoring Committee

Answer 5

Group of independent experts that review the ongoing conduct of a trial to ensure continuing patient safety as well as the validity and scientific merit of the trial

Question 6

Generally accepted principles of DSMB

Answer 6

Certain types of trials should have DSMB

DSMBs should be multidisciplinary

A charter should describe the operations and procedures of a committee

DSMB members should be free of conflicts of interest

Interim data should be considered highly confidential

Question 7

(Independent) DSMB

Answer 7

No member has any basis for preferring gone outcome to be on one or the other direction

No member has ability to influence the trial conduct in a role other than DSMB member

Question 8

Scope of DSMB

Answer 8

Evaluate accumulating data with regard to efficacy and toxicity

Recommend termination or continuation

Recommend study modifications

Review study protocol

Assess study conduct

Recommend additional analyses

Question 9

Structure of DSMB meeting

Answer 9

Open session
-process data
-attended by investigators, sponsor reps, data site reps
Closed session
-interim and outcome data, adverse events by group
Executive Session
- private DSMB member discussion

Question 10

Minimal risk

Answer 10

Probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life