ICH/GCP
According to Principles of ICH GCP, What should be obtained from every subject prior to clinical trial participation?
Freely given informed consent
When reviewing the IP accountability log, you notice there are site staff initials missing for drug dispensation. This entry is not ALCOA+ compliant because it is not _____.
Attributable
For each day of the site visit, which document must be completed by the CRO and/or Sponsor member visiting the site and signed off by a site staff member present at the visit?
Site Visit Log
The _____ is a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects. Its purpose is to provide the investigators and others involved in the trial with the information to facilitate their understanding of the rationale for, and their compliance with, many key features of the protocol, such as the dose, dose frequency/interval, methods of administration: and safety monitoring procedures.
The Investigator's Brochure
During routine monitoring visits, how often should IP accountability be performed?
Every monitoring visit or as specified by the monitoring plan.
By definition, these document the existence of the subject and substantiate integrity of trial data collected. ____ ____ include original documents related to the trial, to medical treatment, and history of subject.
Source Documents
Your favorite study coordinator makes an error while completing source documentation. In order to correct this, she attacks the page with black sharpie, completely covering the original entry. This is a violation of which ALCOA+ principle?
L- Legible
The ____ Log is to be completed by the CRA to track ICF review during their IMV and on each line, the CRA should include the Subject Number and which other 6 items?
ICF Log; Date of Enrollment, Was the ICF Signed?, Date ICF Signed, Monitor Initials & Date, Subject Completion Date, Comments/Issues
Generally, the ____ is/are responsible for ensuring that an up-to-date IB is made available to the investigator(s) and the _____ is/are responsible for providing the up-to-date IB to the responsible IRBs/IECs.
Generally, the SPONSOR is responsible for ensuring that an up-to-date IB is made available to the investigator(s) and the INVESTIGATORS are responsible for providing the up-to-date IB to the responsible IRBs/IECs.
The monitor is responsible for verifying the following for investigational products(s):
a. That storage times and conditions are acceptable, and that supplies are sufficient throughout the trial.
b. That the receipt, use, and return of the investigational product(s) at the trial sites are controlled and documented adequately.
c. That final disposition ensures that documentation is maintained up through IP dispensation and administration
d. A and B
e. A only
f. A, B and C
A and B
a. That storage times and conditions are acceptable, and that supplies are sufficient throughout the trial.
b. That the receipt, use, and return of the investigational product(s) at the trial sites are controlled and documented adequately.
(v) That the disposition of unused investigational product(s) at the trial sites complies with applicable regulatory requirement(s) and is in accordance with the sponsor.
According to ICH GCP the IRB/IEC should conduct continuing review of each ongoing trial how often?
At intervals appropriate to the degree of risk to human subjects, but at least once a year.
When reviewing source, you notice that sticky notes with vitals are included with the site source documentation. You thank your study coordinator for complying with this ALCOA+ principle, because they retained source that is _____.
O- Original
Although PI is responsible for all aspects of conducting a study (according to ICH/GCP), it is best practice to have the PI present on the ________, as this will provide a sample of the PI's handwriting.
Site Responsibility Log
During the conduct of the trial, these documents should be verified as received by PI and filed in the ISF as they contain relevant safety information (ICH/GCP 8.2.1 and 8.3.17)?
Investigator's Brochure Updates, Safety Reports/Notification of SUSARs
Which documents should be reviewed and cross-checked to ensure that the site has the correct inventory on hand?
According to ICH GCP, monitoring responsibilities include:
a. Determining whether all adverse events are appropriately reported within the time periods required by GCP, the protocol, the IRB, and the sponsor
b. Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator and taking appropriate action to prevent recurrence of the detected deviations
C. Reporting the subject recruitment rate
d. A and B
e. B and C
f. A, B and C
f. A, B and C
At an SMV, you notice that the AE log is not up to date, despite the subject reporting worsening of back pain at a previous visit. You have a discussion with the study coordinator, as this data should be entered in a ______ fashion.
Contemporaneous
According to ICH/GCP, _____ are those documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced.
Essential Documents
____ Are defined by the protocol as Events that:
•Do not normally fall within the standard SAE criteria
•Might be expected from pre-clinical study results
Reported to Sponsor within same timeframe as SAE
Adverse Events of Special Interest (AESI)
IP can be destroyed only after written authorization/approval is received by _____?
Written authorization of the Sponsor/delegate
Which of the following is a principle of ICH GCP?
a. Clinical trials should not be conducted if there are any foreseeable risks or inconveniences to trial subjects.
b. The medical care given to subjects should always be the responsibility of a qualified monitor assigned by the sponsor.
c. Clinical trial information should be recorded, handled, and stored in a way that allows accurate reporting, interpretation, and verification.
d. Individuals involved in conducting clinical trials should be qualified by their ability to adhere to ICH GCP.
c. Clinical trial information should be recorded, handled, and stored in a way that allows accurate reporting, interpretation, and verification.
What are the FOUR principles that make up the '+' component of ALCOA+?
The acronym 'ALCOA' defines that data should be Attributable, Legible, Contemporaneous, Original, and Accurate. In addition, 'ALCOA+' guidance recommends that data is also Complete, Consistent, Enduring, and Available.
The Screening and Enrollment Log, Subject ID Log
SAEs must be reported by the investigator to the appropriate Medical Department within what timeframe?
Immediately or within 24 hours after first becoming aware of them
Who is responsible for completing the IP Return Form for any IP returned to the Sponsor/IP vendor?
The CRA