Exam Review Flashcards
It is the 1)____________ responsibility to determine if AEs were reported appropriately in the proper timeframe, it is the 2)_____________responsibility actually report these events.
1)Monitor’s
2) investigator
Who determines requirements and schedule of frequency of monitoring visits?
-determined by the sponsor
- adjusted according to the needs of the particular trial
-not effected by ICH or regulatory guidelines
Who is ultimately responsible for the conduct of the trial, including making time for the trial activities
PI
The monitor follows what for specifics in monitoring a trial?
sponsor’s written SOPs
Who is responsible for quality control and assurance in a trial?
The sponsor
-example: version controlled documents
Who actually reports AEs to sponsor and IRB
investigator
AE Reporting
1) Investigators reports to the sponsor:
2) Sponsors report to investigators and FDA:
3) Investigators and sponsors report to the IRB:
1) Any adverse event (AE) determined to be caused by (or probably caused by) the drug
2) Any AEs associated with the study drug that are both serious and unexpected, as well as any finding from animal research suggesting a significant risk to human subjects
3) All unanticipated problems (UAPs) involving risks to human subjects or others
Source document v CRF
Source data are contained in source documents (original or certified).
A Case Report Form (CRF) is a printed or electronic document designed to record all of the study data about a study participant
The first place data is recorded in a trial is known as ____________
Source document
The _____________________ documents that all closeout activities are complete and that all essential documents are held in the appropriate file.
closeout report
The clinical program typically includes a number of individual clinical trials, and the investigator will likely not have participated in all of them. Therefore, in practice, an investigator may not know the status of the sponsor’s clinical program and so would not know when their record retention obligations under ICH had been met. The investigator in this case is _________________ to notify the site when records retention is no longer required according to the status of their clinical program.
is dependent upon the sponsor
The primary objective of a Phase I study is to:.
-assess the initial safety and tolerability
-pharmacokinetics, pharmacodynamics
The primary objective of a Phase II study
explore therapeutic efficacy.
The primary objective of a Phase III study is
to demonstrate, or confirm therapeutic benefit.
The primary objective of a Phase IV study is
to delve further into the approved IP’s safety, efficacy and dose definition.
If the events are not listed in the IB, the events are considered ________________.
unexpected
Site/investigator selection is a _________________responsibility
What form is used in site selection?
Sponsor
site evaluation form, sponsor specific
Study subject experiences SAE, in what order should people (IRB, PI, Sponsor) be notified?
1) PI should be notified first as he/she is responsible for the subject’s wellbeing while on the clinical trial and should ensure that adequate medical care is provided to the subject for all adverse events.
2) SAEs should be reported immediately to the study sponsor 3)the IRB/IEC per applicable regulatory requirements.
pharmacokinetics
(what body does to drug)
pharmacodynamics
(what drug does to body)
Essential Documents
Documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced
These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good
Clinical Practice and with all applicable regulatory requirements.
DOCUMENTS IN ISF and SUBJECT BINDERS
What kind of documents are CRFs?
Source Documents
Expedited review
review involving minimal risk and minor changes to research previously approved by the full committee
Stratification of study subjects
partitioning of subjects and results by a factor other than the treatment given
_________________ is responsible for the medical care of the subject
PI
All data collected during a trial should be recorded in
CRFs (are also source documents)
Enrollment logs are established (when) _____ initiation of the site
After
Budgets should be in place _________________ to the site initiation visit
prior
An insurance statement is also required to be on file _______________(what site and when) to commencing a study
1) investigator site prior
Pre-study monitoring reports are only required to be located in the file of the ______________
Sponsor
IRB/IEC updates should be submitted ___________by the investigative site.
The timing of these yearly updates are based upon the ___________
annually
initial IRB approval date
A chart review in preparing for research is a ___________ activity and ________ require an IRB review
pre-screening activity and does not require IRB review
Who has ultimate responsibility for activity at site, such as documenting CRF/ICF discrepancies?
PI
All trial-related visits and procedures must be documented in the __________________documents
Source
Subject requires at study related blood draw, but only available tubes are expired. What should be done?
No useable data can be obtained by drawing blood into an expired tube.
It is unethical to subject a subject to an invasive procedure that will produce unusable data.
The best option is obtain an unexpired tube, even if this may delay sample collection.
At minimum, __________________(what trial related collection) should be collected from the time of screening throughout the entire study duration
AEs
Data reported on the CRF should be consistent with the___________
Discrepancies in CRF should be explained by ______________ (who?)
source documents
whoever originally filled it out
Trough level should be drawn ____________ to dosing
prior
The lowest level of the drug in the patient’s body
The monitor should insure that the investigator is (what) ______________________ designed to prevent recurrence of detected deviations from the study protocol
taking appropriate actions
Investigators report SAEs (timeframe) ____________________ to sponsor. Also report to (who) __________ if required by local regulations
immediately, IRB
What document needs to be signed before investigator receives protocol and IRB from the sponsor?
confidentiality agreement
Name a document that the IRB does NOT review
Contract Budget
What type of activities does the monitor perform? (QA v QC)
Quality Control
If the investigator has deviation from protocol, who do they inform?
Sponsor, IRB, and regulatory authorities
Any change or correction to a CRF should be dated, initialed, and explained (if necessary) and should not obscure the original entry. Sponsors should provide guidance to investigators on making such corrections. Sponsors should have written procedures to assure that changes or corrections in CRFs made by sponsor’s designated representatives are documented, are necessary, and are endorsed by the investigator. The investigator should retain records of the changes and corrections.
The __________________ (who?) will be granted direct access to the subject’s original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the subject, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the subject or the subject’s legally acceptable representative is authorizing such access.
monitor, auditor, the IRB, and regulatory authorities
also the investigator
IP should, by default, be ____________ after use
returned to the investigator
*unless an alternative dispossion if authoried by sponsor
