SOCRA Exam Practice | 2023/ 2024 Latest
Update!!! | Questions and Verified Answers|
Rated A Complete Guide
QUESTION
How often and to whom must sponsors submit progress reports in device trials?
Answer:
At regular intervals (at least yearly) - to all reviewing IRBs
If SR device, to FDA at least yearly
QUESTION
How often and to whom do sponsors submit progress reports if device is under a treatment IDE?
Answer:
Semi-annual progress reports to all reviewing IRBs and FDA + annual report
QUESTION
Within how many days should a sponsor notify the FDA of the completion/termination of a SR
device trial?
Answer:
30 working days
QUESTION
Within what time period must a sponsor submit a final report to the FDA, all IRBs and all
investigators after completion/termination of SR device trial?
Answer:
6 months
QUESTION
Who is responsible for ensuring investigators are compliant with GCP requirements?
,Answer:
Sponsors - obtain signed FDA 1572 or Investigator's Agreement stating investigator will comply
with GCP, so usually require training
QUESTION
What 4 items must sponsors provide procedures/instructions to investigators about? (Per ICH
GCP 5.14.3)
Answer:
1) Handling/storage of IP
2) Receiving/dispensing of IP
3) Retrieval of unused IP
4) Return of unused IP to sponsor if authorized and in compliance
QUESTION
What does ICH GCP 5.18.3 state regarding monitoring of investigators by sponsors?
Answer:
Sponsor should ensure trials are adequately monitored. Sponsor determines appropriate extent
and nature of monitoring. There is usually a need for on-site monitoring before, during and after
a trial. Sometimes, sponsor may determine central monitoring + investigators meeting and
training is sufficient
QUESTION
What regulation dictates that investigators and staff should be adequately trained?
Answer:
ICH GCP 5.18.4
QUESTION
Whose responsibility is it to ensure investigators and staff are trained?
Answer:
CTM or CRA
,QUESTION
What 5 types of reports must be made from an investigator to a sponsor?
Answer:
1) Safety occurrences
2) Protocol deviations
3) Progress reports
4) Final report
5) Financial disclosure report
QUESTION
What 6 requirements does ICH GCP state for sponsors regarding IP accountability?
Answer:
1) Ensure timely delivery of IP to investigators
2) Maintain records of shipment, receipt, disposition, return and destruction
3) Maintain system for retrieving IP and documenting it
4) Maintain system for disposition of unused IP and documenting it
5) Take steps to ensure IP is stable over period of use
6) Maintain sufficient quantities of IP, record of batch sample analyses and characteristics, and
retain samples as possible until analyses of trial data are complete
QUESTION
What does ICH GCP 5.1.1 dictate regarding SOPs?
Answer:
Sponsors are responsible for implementing and maintaining QA/QC systems with written SOPs
QUESTION
What is a FDA Form 1571?
Answer:
Cover page for IND application; lists information provided in submission
QUESTION
What is FDA Form 1572?
, Answer:
Statement of investigator
QUESTION
What is FDA Form 3454?
Answer:
Certification of financial disclosure for investigators with no financial disclosures
QUESTION
What is FDA Form 3455?
Answer:
Disclosure statement for financial disclosure of clinical investigators who have disclosable
interests
QUESTION
What is an IND?
Answer:
Application to FDA to seek permission to test a new drug or biologic in clinical trial involving
people
QUESTION
What are the 4 types of INDs?
Answer:
1) Commercial IND: sponsor
2) Investigator IND: sponsor/investigator
3) Emergency Use IND: emergency situations not allowing time for full IND
4) Treatment IND: for drug/biologic showing promise in testing for serious or immediately life-
threatening conditions while final clinical testing and FDA review are taking place
QUESTION
Update!!! | Questions and Verified Answers|
Rated A Complete Guide
QUESTION
How often and to whom must sponsors submit progress reports in device trials?
Answer:
At regular intervals (at least yearly) - to all reviewing IRBs
If SR device, to FDA at least yearly
QUESTION
How often and to whom do sponsors submit progress reports if device is under a treatment IDE?
Answer:
Semi-annual progress reports to all reviewing IRBs and FDA + annual report
QUESTION
Within how many days should a sponsor notify the FDA of the completion/termination of a SR
device trial?
Answer:
30 working days
QUESTION
Within what time period must a sponsor submit a final report to the FDA, all IRBs and all
investigators after completion/termination of SR device trial?
Answer:
6 months
QUESTION
Who is responsible for ensuring investigators are compliant with GCP requirements?
,Answer:
Sponsors - obtain signed FDA 1572 or Investigator's Agreement stating investigator will comply
with GCP, so usually require training
QUESTION
What 4 items must sponsors provide procedures/instructions to investigators about? (Per ICH
GCP 5.14.3)
Answer:
1) Handling/storage of IP
2) Receiving/dispensing of IP
3) Retrieval of unused IP
4) Return of unused IP to sponsor if authorized and in compliance
QUESTION
What does ICH GCP 5.18.3 state regarding monitoring of investigators by sponsors?
Answer:
Sponsor should ensure trials are adequately monitored. Sponsor determines appropriate extent
and nature of monitoring. There is usually a need for on-site monitoring before, during and after
a trial. Sometimes, sponsor may determine central monitoring + investigators meeting and
training is sufficient
QUESTION
What regulation dictates that investigators and staff should be adequately trained?
Answer:
ICH GCP 5.18.4
QUESTION
Whose responsibility is it to ensure investigators and staff are trained?
Answer:
CTM or CRA
,QUESTION
What 5 types of reports must be made from an investigator to a sponsor?
Answer:
1) Safety occurrences
2) Protocol deviations
3) Progress reports
4) Final report
5) Financial disclosure report
QUESTION
What 6 requirements does ICH GCP state for sponsors regarding IP accountability?
Answer:
1) Ensure timely delivery of IP to investigators
2) Maintain records of shipment, receipt, disposition, return and destruction
3) Maintain system for retrieving IP and documenting it
4) Maintain system for disposition of unused IP and documenting it
5) Take steps to ensure IP is stable over period of use
6) Maintain sufficient quantities of IP, record of batch sample analyses and characteristics, and
retain samples as possible until analyses of trial data are complete
QUESTION
What does ICH GCP 5.1.1 dictate regarding SOPs?
Answer:
Sponsors are responsible for implementing and maintaining QA/QC systems with written SOPs
QUESTION
What is a FDA Form 1571?
Answer:
Cover page for IND application; lists information provided in submission
QUESTION
What is FDA Form 1572?
, Answer:
Statement of investigator
QUESTION
What is FDA Form 3454?
Answer:
Certification of financial disclosure for investigators with no financial disclosures
QUESTION
What is FDA Form 3455?
Answer:
Disclosure statement for financial disclosure of clinical investigators who have disclosable
interests
QUESTION
What is an IND?
Answer:
Application to FDA to seek permission to test a new drug or biologic in clinical trial involving
people
QUESTION
What are the 4 types of INDs?
Answer:
1) Commercial IND: sponsor
2) Investigator IND: sponsor/investigator
3) Emergency Use IND: emergency situations not allowing time for full IND
4) Treatment IND: for drug/biologic showing promise in testing for serious or immediately life-
threatening conditions while final clinical testing and FDA review are taking place
QUESTION
