PRIOR TO INITIATION OF THE CLINICAL RESEARCH STUDY

PRIOR TO INITIATION OF THE CLINICAL RESEARCH STUDY

The Investigator should:

Be interested in the scientific aspects of the study and ensure that the study is responsive to the needs of public health within the country of the population in which it will be conducted.

Ensure the confidentiality of the product, the protocol and trial procedures by giving a confidentiality agreement in writing to TDP/TDR and/or sponsoring agencies.

Have sufficient time free from other obligations to prepare and conduct the trial. Clinical trials are time consuming and the Investigator should ensure that sufficient time can be dedicated to the study, including for informing and supervising study staff.

Review Investigator’s Brochure and any up-to-date information on the investigational product. The Investigator must be familiar with the product, including pre-clinical toxicology, pharmacology, pharmacokinetics and up-to-date clinical data.

Review and discuss in detail, the ICH GCP guidelines, investigators' SOPs and protocol with the Clinical Monitor.  The Investigator should clearly define:

1. Factors that may alter the feasibility and acceptability of the trial.

2. An adequate recruitment rate for the trial by providing retrospective data on numbers of patients who would have satisfied the proposed entrance criteria during preceding time periods.

Make sure that the procedures stated in the study protocol are applicable in his/her centre and fully understood. The Investigator should ask the Clinical Monitor to clarify any points of possible misunderstanding.

Make sure that there are sufficient medical, paramedical and clerical staff to support the study and deal with foreseeable emergencies.

1. Provide a list of study personnel and functions in the study to the Clinical   Monitor/Product Manager (Authorized Staff Form - ASF).

2. Provide curriculum vitae of the Sub-co Investigators in the responsible laboratory.

Make sure that the physical location and facilities are sufficient to allow the study to be undertaken efficiently. Ensure:

1. Confidentiality and safety conditions for trial subjects.

2. Adequate equipment/facilities for subject follow-up, examination and care.

3. Adequate facilities for product storage.

4. Adequate facilities for laboratory assay. The laboratory assay should be validated  under good  laboratory practice (GLP) principles.

5. Adequate facilities for retention of trial documents, ensuring confidentiality of all  information about trial subjects and information supplied by TDR/sponsoring agencies.

Discuss the Case Report Form/SAE reporting forms and source documents in detail with the Clinical Monitor.  Clearly define :

1. Who will be responsible for CRF completion.

2. Source documents/source data and access to source data.

Arrange archiving of trial documents according to GCP and regulatory requirements.  It is important to check the duration of retention of patient records with the Institution's archive.  In case the Institution's archive does not ensure retention of documents for the period of time requested by TDR/sponsor, the Investigator must arrange for the retention of the subjects’ source documents/records for the period requested by TDR/sponsor and regulatory requirements.

Finalize informed consent forms and associated trial subject information materials (advertisements); establish procedures for application for local clearance (e.g. dean of the institution) and Independent Ethical Committee (IEC)/Institutional Review Board (IRB) approval.

Clearly define how subjects will be approached and informed, who will inform them, and what material will be used.  The informed consent form and all information (leaflet written in simple language, video) should be developed collaboratively with head members of the study population/ community to ensure methods are appropriate.

In case of the need for screening tests, including biological specimen collection, before entering a trial, two types of consent form should be developed: one for biological specimen collection and analysis, and one for participation in the study after obtaining satisfactory laboratory results and respecting inclusion criteria.

As a rule, the advertisement must not make reference to TDR or the compound, nor make any claims. Informed consent and advertisements must be submitted to TDR for review and must be included in documentation submitted to the Independent Ethical Committee and/or Institutional Review Board (IEC/IRB).