For the introduction on registering clinical trials with CTRI, read our post by clicking the link below:
The process of registering a clinical trial with CTRI consists of eight parts, which will be addressed in this post
Part 1: Title of the Study: This part asks you to enter the
Public Title : Title of the clinical study in simplified non-scientific terms for the general public. eg: Clinical study test the efficacy of mosquito repellent cream
Scientific Title: Title of the clinical study in it’s actual scientific form. eg: The prospective, randomised, comparative, single centre, double blinded clinical study to test the safety and efficacy of mosquito repellent cream in comparison with a regular moisturising cream in healthy children between the ages of 5-10 years.
Acronym: This is optional. Some large, multicentred trials have ACRONYMS to identify and refer to their clinical studies eg: STEMRC – Study to Test Efficacy of Mosquito Repellent Cream
Part 2: Contact details . This section requires details such as secondary ID, contact details of the Principal Investigator of the study along with listed person for scientific and public query from CTRI or general public.
Part 3: Sponsor details: This section details with the name of primary and secondary sponsor as well details about the various countries that this trial will be conducted in.
Primary sponsor refers to the person/organisation with the motive, means and money for the clinical study usually a pharmaceutical company and the secondary sponsor is any contract organisation (CRO) acting on behalf of the said primary sponsor.
Part 4: Condition and Regulatory Clearance: this section allows you to talk about the condition for which the clinical study is being conducted eg: STEMRC woudl be a clinical trial conducted on Healthy Volunteers for skin safety and tolerance.
Part 5: Study Type: Here the clinical study is classified based on the Investigational Product as NCE, CE, product of AYUSH etc. Scientific details such as study design are also captured.
Part 6: Investigational Product: This section captures details of the investigational product inclusive of the comparator agent (mosquito repellent cream and regular moisturising cream) along with details of the patient inclusion.
This is done using very specific set of scientific do and dont called the Inclusion-Exclusion criteria, which will allow the Investigator (doctor) to determine whether a young boy/girl will be eligible to participate in STEMRC
Part 7: Details of the Clinical Study: Here the details of the outcome measures, end points and recruitment status details are captured.
Part 8: Also contains submission Link: This section allows you to write a brief summary about the clinical study allowing you to capture any details or additional data.
The section also contains the submission to CTRI link.
For more details, click to download and read the CTRI Data Set Instructions.