i. To play a lead role in initiating, planning, executing, monitoring and controlling,

analysis and reporting a project

ii. To communicate and present trial effectively whenever needed

iii. To organise and motivate others

iv. To manage the trial budget.

Effective trial management includes the following:

i. Proper planning of the project

ii. Time management

iii. Timely approval of the trial

iv. Proper designing of the clinical trial protocol

v. Good collaboration between the trial staff and participants

vi. Good communication between each section of the trial pyramid

vii. Proper management of the budget

viii. Proper training to the staff

ix. Appropriate credit will be given to the responsible persons

x. Effective recruitment of staff and trial participants

xi. Efficient evidence and study in the support of the trial

xii. Genuine reporting to the competent authority

xiii. Compliance with the regulatory guidelines for clinical trials

xiv. Efficient management of the resources

xv. Good record keeping

Effective management of clinical studies will only be possible if all the stakeholders

come together and ‘own’ the project.

PRACTICE QUESTIONS

Long Answer Type Questions

1. Explain the general considerations of INDA.

2. Explain the procedure for NDA filing in detail.

140 Industrial Pharmacy II

Short Answer Type Questions

1. What are bioequivalence studies? Describe in detail.

2. Explain the importance of biostatistics in drug development process.

3. What are the contents of IB?

4. What are the general considerations for data submission in FDA?

5. Explain the following:

a. Biowavers

b. Management of clinical studies

Objective Type Questions

1. _____filed before conducting clinical trials

a. ANDA b. INDA

c. NDA d. All of the above

2. INDA filing is done for:

a. Conducting animal studies b. Conducting human studies