CRP 101 Lecture 9

Question 1

types of CT that need filing CTA with HC

Answer 1

phases I to III, comparative bioavailability studies. any studies outside the parameters that a marketed procuct was approved under (indication, dosage, population, administration route)

Question 2

emergency CTA-A

Answer 2

file within 15 days of implmenting the changes

Question 3

CTA-N

Answer 3

CTA notification. if changes to protocol do not affect the safety of the participants or the quality of the drug. i.e. site closure, premature discontinuation of trial as in protocol.

Question 4

regulatory requirements (7)

Answer 4

-CTA
-annual progress report to REB
-safety reporting
-REB approval
-trial registration
-record retention
-QA (monitoring, audits, SOPs)

Question 5

health canada role

Answer 5

reviews and aproves or rejects CTAs, assess safety, quality of drugs, assures REB review, reviews ADRs

Question 6

REB roles

Answer 6

-ensure safety, wellbeing, confidentiality, rights of paraticipants
-conclict of interest
-financial agreements

Question 7

audit vs inspection

Answer 7

audit: internal review by QA auditors on CT docs
inspection: external review by regulator body of docs, facilities, etc. located at site, sponsor, CRO, etc
-looking for safety and data integrity, division 5 and GCP compliance, request corrective actions, enforecement

Question 8

inspection strategy for HC (6)

Answer 8

-number of trials at site
-complexity of CT
-number of participants
-number of protocol deviations
-number of SAEs at site
-obervations of past inspections

Question 9

health canada inspections

Answer 9

-80 per yeat
-5 days
-can be unannounced
-tours of sites
-inspector given full access to all study documents and a private office

Question 10

compliance definition

Answer 10

state of conformity of a regulated party or product with a legislative or regulatory requirement or a recognized standard

Question 11

minor observations risk 3

Answer 11

not critical or major but indicates a definiciency or deviation from division 5 (minor doc errors, labelling, drug handling)

Question 12

major observatons risk 2

Answer 12

marked deviation or deficiency other than critical. could casue undue health risks to subjects or invalidate data (QI not qualified, medical care not under QI, not updating ICF with amendments, inadequate source data to support results)

Question 13

critical observations risk 1

Answer 13

observtion of a situation that rsults in fatal, life threatening or unsafe conditions for subjects. Immediate or latent risk to rights, health or safety. (unauthorized trials, falsification of docs, prohibites substances, no AE records, failure to notify HC of amendements)

Question 14

ADR defintion

Answer 14

adverse drug reaction - all noxious and unintended responses to a product related to any dose (dose may not be established yet)

Question 15

AE definition

Answer 15

any untoward medical occurance that happens in a participant that may not be necessarily related to the drug, includes ADRs

Question 16

serious AE defintion

Answer 16

noxious or unintended repsonse to a drug that occurs at any ose and requires hospitalization or prolonged hospitalization, congenital malformation, significant disability or incapacity, life threatening, death

Question 17

ADR reporting

Answer 17

-sponsor expediate reporting to all investigations, instituitions, REB, and reg body of all serious and unexpected ADRs
-15 days if non life threatening
-7 days if life threatening
-send report of implication of fidnings within 8 days of notification to HC

Question 18

unexpeted AE definition

Answer 18

anything that is not known as an AE from the drug. anything not listed in IB.