Control of Clinical Trials Act, 1987

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Number 28 of 1987

CONTROL OF CLINICAL TRIALS ACT, 1987

ARRANGEMENT OF SECTIONS

Section
1.	Interpretation.
2.	Restriction on application of Act, etc.
3.	Application to undertake clinical trial.
4.	Grant of, or refusal to grant, permission to undertake clinical trial.
5.	Amendment of permission to undertake clinical trial.
6.	Conducting of clinical trial.
7.	Revocation of permission to undertake clinical trial.
8.	Ethics committees.
9.	Participants in clinical trial.
10.	Security for compensation.
11.	Information on clinical trials and reports.
12.	Incorrect or misleading information, etc.
13.	Offences.
14.	Onus of proof of pharmacological or harmful effect.
15.	Penalties.
16.	Fees.
17.	Regulations.
18.	Expenses.
19.	Short title and commencement.

Acts Referred to
Dentists Act, 1985	1985, No. 9
Medical Practitioners Act, 1978	1978, No. 4
Petty Sessions (Ireland) Act, 1851	1851, c. 93
Pharmacy Acts, 1875 to 1977
Public Offices Fees Act, 1879	1879, c. 58

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Number 28 of 1987

CONTROL OF CLINICAL TRIALS ACT, 1987

AN ACT TO PROVIDE FOR CONTROL OVER THE ADMINISTRATION OF ONE OR MORE SUBSTANCES OR PREPARATIONS TO PERSONS FOR THE PURPOSE OF ASCERTAINING THE EFFECTS (INCLUDING KINETIC EFFECTS) OF THE ADMINISTRATION OF SUCH SUBSTANCES OR PREPARATIONS ON THOSE PERSONS WHERE SUCH ADMINISTRATION MAY HAVE A PHARMACOLOGICAL OR HARMFUL EFFECT, TO PROVIDE FOR ETHICS COMMITTEES IN RELATION TO THE FOREGOING AND TO PROVIDE FOR OTHER MATTERS CONNECTED WITH THE MATTERS AFORESAID. [22nd December, 1987]

BE IT ENACTED BY THE OIREACHTAS AS FOLLOWS:

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