Terms

Question 1

NPRA

Answer 1

National pharmaceutical regulatory agency

Question 2

Form for schedule for drugs

Answer 2

Form 4, schedule of contro of drug and cosmetics 1984

Question 3

DCA

Answer 3

Drug control authority

Must inform when reporting serious adverse events, within 24 hours

Question 4

IRB

Answer 4

Institutional review board

Independent body
Conprises: medical, scientific and non-scientific member

Question 5

NCCR

Answer 5

National committee for clinical research

Chaired by DG of health, ministry of health

Coordinating and promoting clinical research

Question 6

Quality control (QC)

Vs

Quality assurance (QA)

Answer 6

QC:

• c=continuous review
• done by monitor,
• who will submit written “monitor report” to sponsor
• ensuring trials follow sop, gcp, and applicable regulatory requirement

A:
- periodic, snapshot
- by through audit (by sponsor)
-

Question 7

AE

ADR

SAE/SADR

Answer 7

AE

• any untoward medical occurance starting when consent is signed (regardless weather any IP has been administered or not)
• regardless of any dose
• just write in CRF (no need to tell EC or sponsor)

ADR
-noxius / medical eunfortunate events that happen specifically due to the IP

SAE/SADR

• untoward nedical occurances that cause
  1) death
  2) life-thretening
  3) hospitaisation or prolonged current inpatient stay
  4) persistent/significant disability
  5) congenital defect

Question 8

Source documents

Answer 8

Original / certified printed copy of anything associated with data collection - of patient

• lab notes
• memoranda
• diaries/charts
• graphics/radiographics

Question 9

SOP

Answer 9

Standard operating procedures

Written instruction
To achieve uniformity
Of specific function

Question 10

Where the principles of gcp originate from?

Answer 10

From declaration of Helsinki,
By world medical Association (WMA),
Adopted in June 164

Question 11

Name the first set of research ethics principles for human experimentation

Answer 11

Nuremberg Code 1947

As the result of Nuremberg trial, after WW2,
Addressing medical experiments on concentration camp

Question 12

CRF

Answer 12

Case report form

Question 13

CTIL

Answer 13

Clinicsl trial importlicence

Can be applied by:

1) sponsor people wih address in msia (eg CRO).
2) PI

Must first register with NMMR

CTIL will be issued after receiveing approval from

1) DCA
2) EC/IRB

Valid for 3 years

Question 14

Essential documents

- How long to keep?

Answer 14

Until 2 years after the last aproval for marketing application in an ICH region
And
Until there are no pending /contemplated marketing application

Or
At least 2 years have elapsed since the formal doacontinuation of clinical development of the IP

Question 15

Progress report

- how frequent to give

Answer 15

Give to IRB/IEC yearly (or more frequent if requested)

Question 16

CRO

Answer 16

Contract research organization

Sponsor can partly or wholly appoint a CRO to conduct trial, but sponsor still fully responsible on data quality and integriy.

Question 17

IDMC role

Answer 17

Independent data-monitoring committee

Hired by sponsor to analyze trial data, safey and efficaty critical end points, to determine to stop or cont the trial

Question 18

Ich

Answer 18

International conference (council) of harmonization of technical requirements for oharmaceuticals for human use

ICH brings together all regulatory bodies of europe, japan and usa, and experts from pharma in the 3 regions to discuss scientific and technical aspeys of product registration

It is the organization that provides GCP as std guideline worldwide

Question 19

Essential documenta

3 groups

Answer 19

Before trial

During trial

After trial complete

Question 20

AE reporting

Answer 20

Starts when consent is signed (even before first dose given)

Stops 30 days (follow up) after the last IP dose

Question 21

SAE reporting

When

4 minimum criteria

Answer 21

Immediately to within 24hours (counted from 1st time notified).

PI must report to 2 parties:

1) sponsor
2) IEC

The CRO will notify regulatory authority ie DCA:

• within 7 days if fatal/life-threathebing
• within 15 days if other serious

Essntially 4 person to report:

1) sponsor
2) Ec
3) DCA
4) CRF (write in note)

4 criteria:

1) pt’s details
2) event description
3) suspected medicinal products (if known): dose last taken, name
4) identifiable details of reporter

Question 22

NMMR

Answer 22

National medical research register

Register here 1st before can apply CTIL /CTX

Question 23

Inspection findings

Answer 23

Critical

• adversely affecting rights, safety, and integrity if data
• fraud

Major

Minor
- not affecting subject wellbeing