Southern Adelaide Clinical
Human Research Ethics Committee
Form B – clinical trial drug profile

This form needs to be submitted for drugs that are not on the PBS. Please provide all
the information requested and do not refer the SAC HREC to pages in the Investigator
Brochure.

If the drug/s are approved, a copy of the MiMs is to be provided.

A hard copy of the form is not required by the Ethics office.
1. Drug name
Generic
Proprietary
2. Manufacturer
Source
3. Structural formula
4. Formulation of drug
Description – nature, does size(s)
In vitro properties
In vivo properties.
5. Preclinical
pharmacology
6. Preclinical
toxicology
In vitro
In vivo
Acute toxicity studies.
Chronic toxicity studies.
Reproduction and teratogenicity.
Mutagenicity, carcinogenicity.
7. Pharmacokinetics
Animal data
Human data
8. Results of human
studies
Pharmacological properties in humans (Phases I, II).
Desired effects in participants with target disease states
(Phases II, III).
Unwanted effects (Phases I-III)
1. Therapeutic doses
2. Toxic doses
SAC HREC Form B and C vDec 14
Southern Adelaide Clinical
Human Research Ethics Committee
2.1 Treatment of over dose
9. Proposed clinical
indications
10. Dosage information
Dose form(s) and strength(s)
(Each to include usual
Dose range
dose ranges, etc. and
proposed dose forms,
strengths, range,
Dose frequency
Administration route
frequency and route in the
study.)
11. References
SAC HREC Form B and C vDec 14
Southern Adelaide Clinical
Human Research Ethics Committee
Form C - information required about investigational drug(s)
A CTN application is required for:

non-marketed drugs/devices

marketed drugs but a non-marketed indication

any drugs being repackaged/relabelled.
Title
Principal Investigator(s)
1.
Drug(s) involved in the study
2.
Manufacturer of drug(s)
3.
Company Sponsoring Trial include address and ABN no.
4.
Is study to be conducted in one or multiple centres:
ONE /
MULTIPLE
5.
If multiple centres, is a list of centres and investigators included with the protocol?
YES/NO
Do drug(s) involved have general marketing status in Australia?
YES/NO
If drug(s) has/have been approved for general marketing, proceed to 7. If not, answer 6 first.
6.
For non-marketed drugs:
6.1
If it is a CTX application, then include TGA approval.
6.2
For CTN Scheme, are the following included?

Research Protocol (P)
YES/NO

Investigator’s Drug Brochure (IB)
YES/NO

Statement of marketing or clinical trial approval by acceptable
regulatory
YES/NO
authority (BRBA, PDA)

Summary data package submitted to regulatory authority
YES/NO

Indication of refusal or questioning of previous clinical trial or marketing
YES/NO
application
7.

Evaluation reports from regulatory authority
YES/NO

For already marketed drug, information
YES/NO
Does the proposed study include use of a placebo?
If YES append copy of placebo composition
7.1
In what way does placebo differ from active drug formulation?
SAC HREC Form B and C vDec 14
YES/NO
Southern Adelaide Clinical
Human Research Ethics Committee
8.
Drug(s) to be supplied by:
8.1
Sponsor company:
YES/NO
PBS – if yes, please list drug(s)
YES/NO
Flinders Medical Centre Pharmacy:
YES/NO

Approval of Clinical Trials Pharmacist has been sought
YES/NO

Will FMC Pharmacy be required to:
8.2

o
Dispense items provided by sponsor already packaged and labelled?
YES/NO
o
Pre pack, label and code oral dose forms?
o
Manufacture dose forms eg. IV infusions (cytotoxic and non-cytotoxic),
YES/NO
suspensions, capsules, powders, creams, syringes etc?
YES/NO
Cost to be bourne by:
o
Sponsor/Investigator: have fees been discussed with Clinical Trials
YES/NO
Pharmacist?
o
PBS medication: for any medications supplied via the PBS the co-
YES/NO
payment will be paid by: Sponsor/Investigator
8.3
Is an after hours or weekend pharmacy service required?
YES/NO

(Please
note that standard support for clinical trials is Monday to Friday 0845 to
1700.
The Clinical Trials Pharmacist will discuss the trial specific requirements with

the investigator or study coordinator. If this service is required there will be
associated costs involved.)
If yes, please provide detail:
8.4
Code for trial will be directed to Chief Pharmacist or;
YES/NO
Available via IVRS or similar
YES/NO
Investigator:
o
SAC HREC Form B and C vDec 14