med 18

 

iii. Page size, margins and source: The paper size should be 8.5 × 11.0 inches with a

margin of 1 inch on all sides to avoid obscuring information. The pages should

be properly oriented. The pages should not be scanned because scanned

documents are more difficult to read. Page numbers should only for individual

documents.

iv. Quality of documents and images: The PDF document should produce the exact or

best replication of paper document. The images and documents should not be

resampled. The documents should be named by using the recommended name.

The punctuation, spaces and other symbols should be avoided in file names. The

document should not include any security settings or password. PDF documents

should be properly indexed.

INDA and NDA 139

9.7 MANAGEMENT OF CLINICAL STUDIES

The clinical trial management requires efficient management. Clinical trial consists of

a series of stages. Each of the stages requires effective management. The stages are as

follows:

1. Initiating

2. Planning

3. Executing

4. Monitoring and controlling

5. Analysis and reporting

Managing these five stages is the most effective way of managing clinical studies.

Issues like time constraints, doctor–patient relationships, patient's concerns, lack of

patient participation, improper execution of information and consent form, etc cause

trial failure. Proper management is required to avoid trial failure. Sponsor is responsible

for managing the clinical trials. A dedicated trial manager is appointed by sponsor.

The key responsibilities of a trial manager are as follows: