Navigating the Routemap 

The Clinical trials toolkit has been designed to help researchers interested in planning and conducting clinical trials in India. The routemap serves as a guide for the various steps involved in clinical trials.

While navigating the routemap, please note:

• The positioning of the boxes (from left to right) gives an indication of the process flow.
• All the boxes depicted in the routemap outline steps/processes that are in accordance with Indian GCP and other applicable guidelines and regulations.
• When each individual box (except that coded grey) is clicked, it will take you to a page that has information on the relevant step along with links to resources and guidelines.
• From any individual content page, to return to the routemap, kindly click on the tab labelled routemap, on top of the page.
• A scroll bar with the key components of the routemap has been provided on the right-hand top corner of each page. Clicking on any of the components mentioned will take you to the page that contains information on that step of the clinical trial process.
• The grey coded box merely indicates a step that should have been completed by that stage of the trial.
• The CDSCO mandatory requirements for regulatory clinical trials as described in the New Drugs and Clinical Trial Rules, 2019 and the Drugs and Cosmetics Act (1940) and Rules (1945), amended 31^stDecember 2016 are marked in red. Links to relevant guidelines, regulationsare provided wherever possible.
• All Good Practice requirements are in blue. In most cases, it is best to consider them as mandatory even if the requirement does not have statutory force.
• We recommend that the various approvals and registrations mentioned under the Approvals and Registration Box should be pursued in parallel as they are likely to be time consuming.

Before using the routemap, it is important to think about the following with regard to your trial:

• The research question
• Where you are in the trial process
• The expertise of your trials team and organisation