Regulations

Question 1

Explain the clinical trials regulations 2004?

Answer 1

An area of the medicines for human use- introduces good clinical practice.

Question 2

Trial rules

Answer 2

All subjects must give consent,trials must be scientifically solid,trials must have a clear protocol,trials must be appropriately or properly constituted ethics committee.Only properly qualified staff may be involved.- inclusind physicians to provide care if needed.Should be adequate pre-clinical testing of the product as defined in ICH guidelines for meds.

Question 3

Total subjects -privacy and confidentiality must be respected and assured

Answer 3

Data must be recorded,handled and stored in a way that would allow accurate reporting,interpretation and verification.

Question 4

What must clinical trials do?

Answer 4

THEY MUST MIRROR THE TREATMENT POPULATION AND AN INCLUSION AND EXCLUSION CRITERIA IDENTIFIING THE TREATMENT POPULATION.Clinical diagnosis and standardised measurement scales are useful to determine those who meet the inclusion criteria.Exclusion criteria is met by those who the treatment does not apply to. Eg T1DM for type 2 pts.

Question 5

What about demographics?-

Answer 5

age,gender,ethnicity and social background should also be considered since the disease may be varied with people of different backgrounds.