Define the critical path
The main obstacle a project team faces is the defining of the critical path. In other words, all tasks that need to be carried
out in parallel and sequentially need to be understood—when should they be completed to achieve clinical trial milestones;
how should those activities be performed in order to successfully complete them; what is the end goal; and what are the organization's
strategies? This needs to be structured in such a way that it can be used by other project teams that have to perform clinical
If an organization doesn't have the know-how for global trials internally, the process of structuring the knowledge can be
done step by step as the organization gains experience. If a company already has staff experienced with global projects, the
task is to capture their knowledge and put it in the service of the organization. A project template, developed by senior
staff with input from the different departments, that contains high-level details and strategies can ensure repeated successful
planning—achieving study goals in the shortest amount of time.
The start-up phase of a clinical trial needs a road map that includes the following:
1 Study planning
2 Site selection
3 Site qualification
4 Local EC/IRB submissions
5 Ministry of Health submissions
6 Import process
7 Supplies importation process
8 Site regulatory package approval
9 Clinical supplies at the study site.
Once such a classification is done, define all the activities to be done in parallel and sequentially for each one of the
steps (critical path), including the time needed to perform each activity.
A good understanding of the entire process and sub-process protects against forgetting any of the critical steps.
For example, you may decide to generate a sub-process for site selection activities, and then define the critical path to
select sites for the clinical study. For instance:
2 Site selection:
a. Request for site identification (2 working days).
b. Feasibility questionnaire development (5 working days).
c. Develop site identification strategy (2 working days)
d. Create the preliminary potential site identification list (1 working day)
e. Develop final potential site identification list (1 working day)
f. Contact sites. Collect the information (10 working days)
g. Identify sites for qualification (1 working day).
h. Investigator database update (1 working day)
New sub-processes can be generated until the people responsible for carrying out the activities feel comfortable and understand
what, when, and who should do the work.