Project Outline
Formulation
General Drug Information
Generic Name
Strength
Reference
Formulation
(USFDA)
Type of Formulation
Indication and
Usage
Manufactured by:
Limitations of Use:
Dosage and
Administration
Mode of
Administration
Regulatory Feasibility
Target submission
Regulatory status of
drug in India
Regulatory status of
drug in other
countries
New/Old Drug
Which CDSCO
checklist to be
followed
Documents
required from
sponsor
Approved in
Known Pharmacokinetics of the drug
As per USFDA Label
Tmax
Key points
Study Proposal
Regulatory Specific
Guidance
Design of the study
Page 1 of 2
Project Outline
Formulation
Main
Inclusion/Exclusion
Criteria
Methodology
Number of subjects
1.
1.
Sampling Timepoints
Analyte to be
measured
BE based on
Additional
comments as per
OGD
Indication
Average
recruitment
rate/site
Number of Patients
to be enrolled
Number of
proposed sites for
the study
Study duration
(Recruitment +
Treatment)
Detailed Study
Timelines
Site feasibility and timelines
Adult cancer patient
X patient/month per site
XX subjects in order to get 28 evaluable patients
X sites
X months (X months recruitment + X month treatment)
(1) Protocol & associated document finalization including site level documents for
DCGI Application = X month
(2) Pre-study activities including DCGI Approval = X months
(3) Recruitment/treatment period = X months
(4) Post study activities including QA audit & CRF retrieval & submission to Sponsor
= X month
(5) Report Preparation= X month
Total timelines from Protocol initiation to report submission = X months
Key challenges/Risks identified in the study
Design related
challenges/risks
Operation
related
challenges/risks
Overall study
Page 2 of 2