DOA Log
The list of items assigned to study staff.
What is the Delegation Task list?
The person responsible for fixing errors in documentation.
Who is the CRC/study team?
(The monitor can help and provide guidance)
SDV
What is Source Data Verification?
A written study plan on which the clinical trial is based. It describes what types of people may or may not participate in the trial, the schedule of activities, length of the study, etc.
What is the protocol?
In addition to ensuring:
a) The rights and well-being of human subjects are protected
b) The reported trial data are accurate, complete, and verifiable from source documents
It is the purpose of monitoring in a clinical trial.
What is to ensure compliance?
(With the approved protocol, GCP guidelines, and regulatory requirements.)
The person responsible for all tasks unless otherwise delegated.
Who is the Principal or Qualified Investigator?
The Monitor can review a participant's informed consent form at this time.
What is at any monitoring visit?
An ongoing process to review the progress of a clinical trial.
Part of Quality Control.
What is Monitoring?
Responsible for writing the monitoring plan.
Who is the Sponsor?
1) Be appropriately trained
2) Have the scientific and/or clinical knowledge needed to monitor the trial adequately
3) Have their qualifications documented
What are the requirements to be a monitor for a clinical trial?
A requirement to be delegated tasks that involve medical decisions.
What is an appropriate medical license?
A set measurement that is described in the protocol and is used to evaluate the effect of an intervention on participants.
What is an outcome/endpoint?
IMV
What is Interim Monitoring Visit?
Describes the monitoring strategy, the monitoring methods to be used, and the rationale for their use.
What is the monitoring plan?
A communication technique that provides a permanent record. It may not be appropriate at all times because it can be time-consuming, impersonal and delay responses.
What is written communication?
The date that officially identifies when the study staff can begin completing their delegated tasks.
What is the date of PI approval signature?
At an interim monitoring visit, you note that Hb in EPIC is 14.6 g/dL, and Hb in Dacima is 16 g/dL.
As the monitor you would do this.
What is query the site to review the source and update if needed?
An examination at a single point in time, not completed by a regulated authority.
Part of the Quality Assurance of the study.
What is an audit?
A patient must do this to be considered a participant in the study.
What is print their name, sign, and personally date the informed consent form?
During a remote monitoring visit, what are these 3 things to keep in mind:
1) Ask sites to electronically transfer identifiable data
2) Accept review of de-identified copies of source
3) Expect the visit to take the same amount of time as an in-person visit
What are things not to do?
The regulation or guidance that dictates the need for a Delegation of Authority Log.
What is ICH GCP?
Should be checked by the Monitor during review of participant eligibility.
What is checking all eligibility criteria and confirming PI approval of enrollment (wet-ink signature or email confirmation)?
Completed remotely. Examines data trends across sites.
Provides additional monitoring capabilities that can reduce the extent or frequency of on-site monitoring.
What is centralized monitoring?
The plan that describes the management of essential documents.
What is the Trial Master File (TMF) Plan?
According to GCP, the Monitor should follow these when monitoring a clinical trial:
a) Site SOPs
b) Sponsor SOPs
What are Sponsor SOPs?