if yes give justification Have you included format/ proforma in PIS & ICF- Marathi: yes or No Yes your protocol for patient information PIS & ICF- Hindi: yes or No Yes sheet (PIS) & Informed Consent Form PIS & ICF- English: yes or No Yes (ICF) in local language/patients any language language as per Schedule-Y of THE DRUGS AND COSMETICSRULES, 1945 Statistical analysis Appropriate Statistical analysis will be done using SPSS/ Gpi into Statistical progressives wherever applicable. Are Any Likely Adverse effects / complications related to this clinical study if any?and mention measures for No. its management. Give details of : Proposed compensation & reimbursement of incidental expenses and management of research related and - unrelated injury / illness during and research period. Is there any financial burden to the patient due to this research project..? No. eg investigation, medications, surgicals, etc
if yes give justification Have you included format/ proforma in your protocol for patient information sheet (PIS) & Informed Consent Form (ICF) in local language/patients language as per Schedule-Y of THE DRUGS AND COSMETICSRULES, 1945 PIS & ICF- Marathi: yes or No Yes PIS & ICF- Hindi: yes or No Yes PIS & ICF- English: yes or No Yes any language Statistical analysis Appropriate Statistical analysis will be done using SPSS/ Gpi into Statistical progressives wherever applicable. Are Any Likely Adverse effects / complications related to this clinical study if any?and mention measures for its management. No. Give details of : Proposed compensation & reimbursement of incidental expenses and management of research related and unrelated injury / illness during and research period. - Is there any financial burden to the patient due to this research project..? eg investigation, medications, surgicals, etc No.