API investigation

1. Basic principles for institutional clinical research
Procedures should be based on following basic
principles and conditions
Existence of clear-cut written policies and
procedures for the approval, management and
control of investigational drug studies in clinical
research
Assurance of adequate safeguards for the
institution itself, staff of the institution, the
scientific integrity of the study and, especially, for
patients

2. Guidelines and conditions
• General guidelines
• Existence of a clinical research committee
• Approval from the from institutional review
committee
• This committee must also monitor approved
studies to ensure they are carried out
appropriately
• Patient consent
• Written patient consent and where not possible,
a verbal or proxy authorization from a legal
representative must be obtained to participate in
the study

3. • Supervised under competent personnel
• Availability of research facilities
• Self-regulatory nature of research
• The research must be self-regulated and to be
terminated on evidence of:
• Significant hazard
• Drug ineffectiveness
• Study results not to be used for promotion
• Result will not be used as its promotion until the
completion of investigation and confirmation
• Exchange of scientific findings in scientific
communications media is not restricted

4. Guidelines for research drug control system
• Existence of an effective control system
• Effective control system for
• Availability, storage, proper packaging, labeling
• Prescription from authorized practitioner
• Ensure that only authorized practitioners will prescribe
the medication
• Record keeping
• Dispensing a record, Amounts of drug received from the
sponsor, amounts dispensed to patients and returned to
the sponsor
• Receiving drug at another facility
• If the patient is to receive the drug at another facility,
suitable arrangements for its transfer must be made

5. Guidelines for pharmacists
• Pharmacist should prepare an ‘investigational drug
data sheet’
• Concisely summarizes for the medical, nursing and
pharmacy staffs
• Containing information pertaining to use of the drug
• This form should contain minimally:
• Drug designation and common
• Dosage forms and strengths available
• Usual dosage range, including dosage schedule and
route of administration
• Indications

6. • Data sheet with study protocol submitted
to the IRC
• Copies should be distributed to pharmacy
staff to familiarize them and all patient
care units where the drug will be used.
• Possession of an approved research copy
• A pharmacist must have a copy of the
institutional review committee - approved
research protocol in the pharmacy.

7. • Maintenance of drug inventory record
• Pharmacist should maintain an investigational
drug inventory record
• This form should contain the following
information
• Drug’s name
• Dosage form and strength
• Lot number

8. • Name, address and telephone number of the
sponsor
• Information needed for ordering the drug
• Amounts dispensed
• Names of patients receiving the drug and
prescribers
• Amount currently in hand

9. • Patient education and monitoring of therapy
• Returning of unused drugs
• Preparation of a statistical summary
• Cost allocation

10. • Expected therapeutic effect.
• Expected and potential untoward effects,
symptoms of toxicity and their treatment.
• Contraindications.
• Storage requirements.
• Instructions for dosage preparation and
administration.
• Instructions for disposition of unused doses.
• Names and telephone numbers of principal
and authorized co-investigators.