Definitions For CTIMPs

Question 1

Authorised health professional… CI and PIs must be an approved professional… some examples of the professionals and what defines them?

Answer 1

Doctor, dentist, nurse, pharmacist, optician
Osteopath, chiropractor

Professional registered under the Health Professions Order 2001

Question 2

Does the CI for a multi-site study have to be a investigator at one of the sites?

Answer 2

No

Question 3

Clinical trial… Has three intentions. What are they?

Answer 3

1) verify pharmacological or pharmacodynamic effects of one or more medicinal products
2) identify adverse reactions to one or more products
3) to study the pharmacokinetics of one or more products to assess their safety/efficacy

Question 4

What is an investigational medicinal product?

If a drug has an MA what three purposes will qualify it being regarded as an IMP?

Answer 4

Pharmaceutical form of an active substance or placebo being tested or used in a trial

1. Used assembled (formulated/packaged) in a way different to its MA
2. Used for a purpose that is not included in the smPC under its MA (e.g. different patient group)
3. Used to gain further info about the form of that product within its MA

Question 5

A non-interventional trial is the study of one or more products with an MA. To be classed as this it must meet 5 conditions. What are they?

Answer 5

1. Products must be prescribed in manner stated in its MA
2. The assignment of a participant to a therapy is not decided in advance by the trial protocol.
3. The decision to prescribe a therapy is clearly separated from the decision to include a patient in the study.
4. No diagnostic or monitoring procedures are applied to patients included in the study (other than SOC)
5. Epidemiological methods are to be used for the analysis of data resulting from the study.

Question 6

What occurrences would be classifieid as an SAE? (5 in total)

Answer 6

1. Death
2. life-threatening
3. causes/extends hospitalization
4. causes persistent/significant disability or incapacity
5. Consists of a congenital anomaly or birth defect

Question 7

Can more than one person act as sponsor for a CTIMP?

Answer 7

Yes.

CT regulations allow for two or more persons to take on this role. Where this applies, one should take the responsibility for:

• communicating amendments and EoT reports
• communicating urgent safety measures
• pharmacovigilance reporting

Question 8

To be classed as substantial, and amendment must impact at least one of four aspects of the trial…. what are they?

Answer 8

1. Safety or mental integrity of the subjects.
2. Scientific value.
3. Conduct/management of the trial
4. Quality/safety of the IMP for the trial

Question 9

The clinical trial regulations define a SA in regards to the CTA (From the MHRA) rather than the REC…

Does the sponsor have to notify REC?

Answer 9

Yes.

In situations where the amendment relates to the REC application or supporting documents

Question 10

Difference between SAE and SAR

Answer 10

Causality.

SAT is related to dose administered to the participant. SAE may not be.

Question 11

SUSARs are an event that does not match with the information about the IMP specified in two documents…. what are they?

Answer 11

The MA and the IB