ISF
Documents that should be filed in the ISF?
FDF, UDPD, CV, Protocol, ICF, safety letter, IB signature page, important communication, Vendor manuals, logs.
Name one purpose of a monitor?
To ensure
1)Rights of subjects are protected. 2) Submitted data is accurate, complete and verifiable. 3)Study is complying with applicable ICH-GCP and FDA regulations.4)Accurate drug Inventory, appropriate dispensing and proper storage conditions
Any untoward medical occurrence to a patient given a pharmaceutical product and that at any dose; Leads to death, hospitalization, birth defects, disability or is life-threatening.
What is a 'Serious Adverse Event"
A sub-I consenting a potential study subject should not be listed on the site's DoA or 1572. True or False?
False.
Are site required to record vitamins/supplements as con-med?
Yes, Any drug taken other than the study IP is considered a con-med.
Name 3 Logs in the ISF?
ICF log, Subject Identification log, Screening& Enrollment Log, Training Log.
The document outlining the design of a study, describing the objectives, methodology and overall organization?
What is Protocol
How long does the site have to report an SAE from time of awareness?
What is "24 hours"
A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial. After having been informed of all aspects of the trial.
Informed Consent Process
Should the site dispose of a sticky note used to record vitals during a visit?
No- Every originally captured piece of data must be retained, rather then replaced or deleted.
What does ALCOA+ mean?
What are the two main functions of a CRA during monitoring site visits?
SDV and SDR
What does SUSAR stand for
Suspected Unexpected Serious Adverse Reaction
All study procedures and assessments should only be done after subject has voluntarily signed study ICF. True or False?
True
Is whiteout allowed for source document correction/changes?
No, make single line through original entry and initial/date correction(with current date)
Original information should still be visible
A new Sub-I has joined the study team.
What documents do you review as a CRA on site?
UDPD, FDF, CV, GCP certificate, sponsor specific/protocol and non protocol trainings and SSRL.
What are two important reviews that should be done at every site visit?
ICF review
SAE review
What events constitutes an SAE?
What is Death, Hospitalization, Birth defects, Disability, Life-threatening, Investigator/Sponsor discretion.
When there's a protocol amendment should the CRA review consents of existing site subjects. True or False?
True
What are ways of building your relationship with your sites?
Initiating weekly contact. Timely response to emails and phone calls. Cultivating a relationship with PI, site coordinator and other site staff. Suggesting ways to help resolve study issues/action items.
What is the FDA 1572 form?
The form shows that the investigator agrees to follow the U.S. Food and Drug Admin (FDA) code of Federal Regulations for the clinical trial.
Provides sponsor with information about Investigator/sub-Is and the site.
Inform the Investigator of his or her obligation.
The document provided to outline the unique monitoring requirements for Tigermed and Sponsors?
What is the Monitoring Plan.
What does SAE Review entail?
Refer to PPT slide
What does ICF Review entail?
Refer to PPT slide
The amount of pages a Tigermed monitor should verify on site?
What is 50- 70 pages per day on site.