PART B TECHNICAL DETAILS – Title of the dissertation Introduction Problem statement Rationale Novelty Expected outcome and application Research question(s) Research hypothesis (es), if any Aim and objectives: Primary objective(s) & secondary objective(s) Review of literature Methodology Study design Study participants (human, animals or both) Inclusion criteria Exclusion criteria Withdrawal criteria, if any (trial-related therapy, follow-up and documentation are terminated prematurely as it is indicated to ensure safety of the participants) Rescue criteria, if applicable (starting symptomatic therapy either to control symptoms of disease or to overcome lack of adequate efficacy of the study drug or placebo) : Number of groups to be studied, identify groups with definition Sampling Sampling population Samplesize calculation Sampling technique Randomization details (for interventional studies)- Intervention details with standardization techniques (drugs / devices / invasive procedures / noninvasive procedures / others) Study procedure Data collection methods including settings and periodicity If the clinical trial, whether registration with CTRI will be done Are the to be used approved for these indications by Drug Controller General of India (DCG-I)? (Enclose the approval letter for the drug/device from DCG-I for trial on humans or give undertaking to get the approval from DCGI; For all drugs and devices submit documents showing DCGI approval for the proposed indication of the study) List of variables and their measurement methods with standardization techniques Independent variables Outcome variables Confounding and interacting variables List variable wise statistical tests to be used for data analysis List and benefits of the study
PART B – TECHNICAL DETAILS Title of the dissertation Introduction Problem statement Rationale Novelty Expected outcome and application Research question(s) Research hypothesis (es), if any Aim and objectives: Primary objective(s) & secondary objective(s) Review of literature Methodology Study design Study participants (human, animals or both) Inclusion criteria Exclusion criteria Withdrawal criteria, if any (trial-related therapy, follow-up and documentation are terminated prematurely as it is indicated to ensure safety of the participants) Rescue criteria, if applicable (starting symptomatic therapy either to control symptoms of disease or to overcome lack of adequate efficacy of the study drug or placebo) : Number of groups to be studied, identify groups with definition Sampling Sampling population Samplesize calculation Sampling technique Randomization details (for interventional studies)- Intervention details with standardization techniques (drugs / devices / invasive procedures / noninvasive procedures / others) Study procedure Data collection methods including settings and periodicity If the clinical trial, whether registration with CTRI will be done Are the to be used approved for these indications by Drug Controller General of India (DCG-I)? (Enclose the approval letter for the drug/device from DCG-I for trial on humans or give undertaking to get the approval from DCGI; For all drugs and devices submit documents showing DCGI approval for the proposed indication of the study) List of variables and their measurement methods with standardization techniques Independent variables Outcome variables Confounding and interacting variables List variable wise statistical tests to be used for data analysis List and benefits of the study
Integrated-form-for-UG-research-protocols-Version-3.0-dated-27th%20July%202018.docx