Introduction

Question 1

Define randomization

Answer 1

Process whereby a participant is allocated by chance to one of the study groups

Question 2

Define blinding

Answer 2

Study team members and participants don’t know into which group a participant is allocated until the trial is over

Question 3

Define bias

Answer 3

When things affect the outcome that shouldn’t (ie not the intervention)

Question 4

What are the 4 phases of a clinical trial?

Answer 4

1. First in human trials
2. Proof of concept trials
3. Registration trials
4. Postregistration trials

Question 5

What is the first phase of a clinical trial?

Answer 5

First in human trials
- healthy participants
- very small sample size 10-20
- only to exclude major safety issues

Question 6

What is the second phase of a clinical trial?

Answer 6

Proof of concept trials
- healthy, uncomplicated participants with the disease
- small sample size (50-100)
- primarily testing for safety
- sometimes additional data collected for dosing, pharmacokinetics and immunology

Question 7

What is the third phase of a clinical trial?

Answer 7

Registration trials
- participants with disease (advanced, comorbidities)
- large sample size 1000s
- safety
- efficacy

Question 8

What is the fourth phase of a clinical trial?

Answer 8

Postregistration trials
- new study population
- new combinations
- extended monitoring
- usability

Question 9

At what point can sponsors apply for registration of the product to be used non-experimentally?

Answer 9

After registration trials are complete

Question 10

Discuss the role of the sponsor

Answer 10

Sets up the study
Pays for the study
Appoints the researcher
Writes the protocol
Oversees the process
Provides study infrastructure

Question 11

Discuss the role of the research team

Answer 11

Conducts the study

Question 12

Discuss the role of the monitors an auditors

Answer 12

Link the sponsor and the research team
Monitor conduct of the research

Question 13

Discuss the role of the ethics committee

Answer 13

Represents the interests of the research participants
Oversees rights, safety and well-being of participants by approving and monitoring research activities and documentation

Question 14

Discuss the role of the SAHPRA

Answer 14

South African Health Products Regulatory Authority
Responsible for all health products in South Africa

Question 15

Discuss the role of the inspectors

Answer 15

Check compliance by the research team and sponsor to protocol and GCP guidelines

Question 16

Discuss the role of the community advisory boards

Answer 16

Represent the community
Advise the research team on community issues, opinions and preferences

Question 17

Discuss the role of the SANCTR

Answer 17

South African National Clinical Trials Register
Database accessible by the public that lists all ongoing trials on the country

Question 18

What are the steps of a clinical research study?

Answer 18

1. Formulate research question
2. Prepare summary proposal
3. Find funding and make a team
4. Write protocol
5. Seek approval
6. Conduct study and collect data
7. Analyse data
8. Prepare study report

Question 19

What are the ALCOA CCEA principles?

Answer 19

A - Attributable: we are able to link an entry in the source to a person (who made the entry)
L - Legible: needs to be readable and clear
C - Contemporaneous : made in real time
O - Original : not a copy, true source (first entry)
A - Accurate: a true reflection of the data collected
C - Complete: no open spaces or left out information
C - Consistent: tells a story that makes sense
E - Enduring:lasts as long as it needs to
A - Available: easily retrievable to work with and review

Question 20

Name Serious Adverse Events (SAE)

Answer 20

1. Death
2. Life threatening
3. Hospitalisation/prolonged
4. Significant disability/incapacity
5. Birth defect/congenital abnormalities
6. Any other serious medical event