Form M.c. 20 - Indemnity Form For Conducting Clinical Trials printable pdf download

Form M.c. 20 - Indemnity Form For Conducting Clinical Trials

Form M.C. 20

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CONFIDENTIAL

MEDICINES CONTROL COUNCIL

MEDICINES AND ALLIED SUBSTANCES CONTROL ACT (CHAPTER 15:03)

INDEMNITY FORM FOR CONDUCTING

CLINICAL TRIALS

(To be completed in triplicate)

I/We ……………………………………………………………………………………………………… ……...

to whom authority has been granted in terms of Subsection (2) of Section 18 of the Medicines and Allied Substances

Control Act (Chapter 15:03) to utilise the medicine or allied substance for the purposes of conducting a clinical trial

therewith upon persons/animals, declare that I/We have read and understood the conditions contained in such authority

and hereby indemnify the State, the Secretary for Health and Child Welfare and the Authority (and any committee

thereof) from liability in respect of any injury or adverse effect whatsoever which may be sustained by any person or

animal, directly or indirectly, as a result of the conduct of the trial and which occurs or reveals itself at the time of the

trial or subsequently (at any time) and further indem nify the aforementioned against any claim for damages, howsoever

arising notwithstanding the proviso to section 28 of the said Act.

Dated at ………………………………….

this day of ………….. 20 ….

………………………………………………

Form M.c. 20 - Indemnity Form For Conducting Clinical Trials