Project Management

Question 1

What is project management?

Answer 1

The process of setting up systems and co-ordinating activities to make sure that the trial runs smoothly is project management.

Question 2

What are the five basic steps of project managment?

Answer 2

1. Initiating
2. Planning
3. Executing
4. Controlling
5. Closing

Question 3

List some things that could go wrong with a trial if managed poorly

Answer 3

Hiring staff
Equipment Provision
Training staff
Central management 
Data collection, entry and verification 
Sourcing intervention

Question 4

How do you define the project management team?

Answer 4

The ICH GCP guidelines define the project management team as a group of multidisciplinary professionals charged with the responsibility for setting up and completing a specific project.

Question 5

What are the general qualities that may benefit the leader of the PMT?

Answer 5

Leadership skills 
Excellent presentation skills 
Organisation 
Ability to motivate others 
Ability to delegate tasks appropriately 
Have flair and enthusiasm 
Be able to manage a budget 
Strategic and tactical vision 
Good communication skills

Question 6

What sort of problems might a local investigator find when evaluating a site?

Answer 6

Insufficient patient pool 
Insufficient personnel 
Lack of time to conduct the trial
Insufficient knowledge of the trial protocol 
Trial communication plan is not working

Question 7

Who provides funding for clinical trials?

Answer 7

1. A commercial organisation such as the pharamceutical industry
2. Charities
3. Government funded medical research bodies (e.g. MRC)

Question 8

What are the key budget categories to consider?

Answer 8

Key budget categories include personnel, equipment, materials and supplies, travel, patient care and other costs

Question 9

What are the main reasons that budgets are not adhered to?

Answer 9

Staff costs - staff hired too early, higher than budgeted salary costs, incremental/ inflationary costs not considered

Intervention costs higher than expected - price rises since first quoted, packing and transportation not specifically budgeted for

Timelines not respected (delays in the study set-up, delays in patient recruitment, delays in declaring a clean database)

Number of patients initially planned for is not sufficient to answer the research question - additional patients will need to be recruited

The number of selected sites is not sufficient to recruit the required number of patients - new sites have to be recruited

The follow up duration planned in the protocol is not long enough - study follow-up has to be extended

Question 10

What are the most likely sources of legal difficulties in clinical trials?

Answer 10

Complaints
Litigation
Insurance