3.1.

Disease Condition

3.2.

Description of Investigational Product

3.2.1.

Composition

3.2.2.

Justification for Route of administration, indicated dosage & duration of therapy

3.2.3.

A summary of findings

3.3.

Description of Population

3.4.

Compliance with Protocol & ICH-GCP guidelines

5.1.

Primary & Secondary End Points

5.2.

Trial Flow Chart

5.3.

Visit Specific Schedule

5.4.

Randomization & Blinding

5.5.

Investigational Product Accountability

6.1.

Subject Inclusion Criteria

6.2.

Subject Exclusion Criteria

6.3.

Subject Discontinuation Criteria & Protocol Deviation

6.3.1.

Subject Withdrawal Criteria

6.3.2.

Subject Drop out /Lost to follow up Criteria

6.3.3.

Protocol Deviation

7.1.

Treatment Medication

7.2.

Packaging & Labeling

7.3.

Permitted and/or Prohibited Medication and/or Treatment

7.4.

Monitoring Subject Compliance

8.1.

Specification of Efficacy Variables

8.1.1.

Primary Efficacy Variable

8.1.2.

Secondary Efficacy Variables

8.2.

Timing of recording, assessing and analyzing efficacy variables

9.1.

Specification of Safety Variables

9.2.

Timing of recording, assessing and analyzing safety variables (Including Laboratory Variables and Adverse Events/Serious Adverse Events/Adverse Drug Reactions)

© 2006 Vedic Lifesciences