Trial interventions

[Guest guest]

Hi,

After having described the Study design one needs to mention in detail about the trial intervention/s which refers to the treatment under investigation and any active control treatment.

Detail in this section may be referenced to other documents, such as the Investigators Brochure or Summary of Product

General information

 Full name, generic name and brand name (if applicable).

 Summary of known and potential risks and benefits to human subjects.

 Whether approved from regulatory bodies

Use within the trial

 Description and justification for the proposed route of administration, dosage, and treatment period.

 Detail of who will be administering the product (e.g. patient, nurse, doctor, others).

 Is the treatment invasive / does it involve radioactive substances?

 Description of dosage form, packaging and labeling of products.

 Description of dispensing records, accountability and disposal procedures during the trial.

 Details of who will supply the products.

 Other detail including shelf life, arrangements for storage etc.

 Arrangements for continuation of treatment for study patients after the end of the trial.

 Other medications permitted during the trial - include rescue medication (could be standardised for the purpose of the trial). It is important also to consider possible interactions or effects that could confound results / conclusions.

Dr. Smita