Module 8

Question 1

Early preclinical development Goals:

Answer 1

1. Determine if the product is reasonably safe for initial human use
2. Compound exhibits pharmacological activity that justifies commercial development

Question 2

Research investigations in which people volunteered to test new treatment, interventions or test as a means to prevent, detect, treat, or manage various diseases or medical conditions.

Answer 2

Clinical trials

Question 3

7 stakeholders:

Answer 3

Participants in clinical trials
Funders and sponsors of the trials
Regulatory agencies
Investigator
Research institutions and universities
Journals
Professional societies

Question 4

Period of waiting after application of IND?

Answer 4

30 calendar days

Question 5

Clinical trial core documents:

Answer 5

Investigators brochure
Clinical study protocol
Subject information and informed consent form
Clinical study reports
Case report form

Question 6

Contains pre-clinical and clinical information
related to an investigational drug.

Answer 6

INVESTIGATOR’S BROCHURE (IB)

Question 7

Document where all of the objectives and designs of a clinical study will be documented. contains instructions for all the parties
involved in the clinical trial that establish specific objectives for each participant and
provide guidelines.

Answer 7

CLINICAL STUDY PROTOCOL

Question 8

describes major changes to the initial Study
Protocol; must be again approved by the Ethics Committee.

Answer 8

Protocol amendment

Question 9

One of the most important elements of
system ensuring the ethics of medical
experiments and protection of the rights of
the study subjects; should be documented
by means of a written, signed and dated
___ ___ Form (ICF).

Answer 9

Informed consent

Question 10

is a process by which a subject voluntary confirms his/her willingness to participate in one or another clinical trial, after having been informed of all aspects of the study.

Answer 10

INFORMED CONSENT

Question 11

The Investigator should provide written reports on study progress to the Ethics Committee. These may be the:
❖Interim report
❖Final report

Answer 11

STUDY PROGRESS REPORTS

Question 12

The results of the study and their assessment
based on the analysis conducted in the course of the study.

Answer 12

Interim report

Question 13

–The full, comprehensive description of the study including description of investigational materials, study design, and presentation and assessment of results of statistical analysis.

Answer 13

Final report

Question 14

major changes that might affect study conduction and/or increase risk to study subjects:
❑ Adverse Event Report/Adverse Drug Reaction Report
❑ Patient Entry Form (Patient Entry Card/Patient Notification Form)
❑ Patient Withdrawal Form, Protocol Deviation/Violation Report, Study Termination Report etc..

Answer 14

NA

Question 15

A paper or electronic document designed to
record all the information for an individual
study subject required by the Study protocol. Helps facilitate the effective, comprehensive
data processing and analysis, results
reporting, and to promote the safety data
sharing between the study team and other
departments of the institution.

Answer 15

CASE RECORD FORM (CRF)

Question 16

7 criteria for ethical clearance of a research protocol:

Answer 16

▪ Scientific validity
▪ The nature and gravity of the risk to human subjects
▪ The adequacy of safeguards and protection against risk
▪ The magnitude of potential benefits or harm to individuals or community
▪ The validity of the study participants informed consent
▪ The ecological impact
▪ Clarification of potential conflicts of interest

Question 17

the first clinical trials done among people.
▪ They aim to learn how a drug is processed in the body and how it affects the body.
▪ In these trials, a very small dose of a drug is given to about 10 to 15 people.
▪ Some clinical trials may not start from phase __

Answer 17

Phase 0

Question 18

aim to find the best dose of a new drug with the fewest side effects. The drug will be tested in a small group of 15 to 100 patients.
▪ Doctors start by giving very low doses of the drug to a few patients.
▪ Higher doses are given to other patients until side effects become too severe or the desired effect is seen.
▪ Phase___ trials are to test a drug’s safety.

Answer 18

Phase I

Question 19

further assess safety as well as if a drug
works.
▪ Phase II trials are done in larger groups of patients compared to Phase I trials.
▪ Often, new combinations of drugs are tested.
▪ Patients are closely watched to see if the drug works. However, the new drug is rarely compared to the current (standard-of-care) drug that is used. If a drug is found to work, it can be tested in a phase III clinical trial.

Answer 19

Phase II

Question 20

compare a new drug to the standard-of-care drug. These trials assess the side effects of each drug and which drug works better.
▪ Phase __ trials enrolls 100 to 1000 patients.
▪ Often, these trials are randomized.

Answer 20

Phase III

Question 21

test new drugs approved by the FDA. The drug is tested in several hundreds or thousands of patients. This allows for better research on short-lived and long-lasting side effects and safety.
▪ For instance, some rare side effects may only be found in large groups of people. Doctors can also learn more about how well the drug works
and if it’s helpful when used with other treatments.

Answer 21

Phase IV (post marketing surveillance)

Question 22

are any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s)

Answer 22

Clinical trials