Listen Toolbox | Overview Tools, templates, policies & guidelines Templates/Tools Template for documentation of Informed consent discussion Eligibility checklist Meeting agenda template Meeting minutes template PI oversight meeting log Specimen tracking log Staff signature and delegation log Delegation of responsibility grid Telephone contact log Training documentation log DSMB charter template Investigator-initiated protocol templates Regulatory Initial IND application IND annual report Request to BCH for IND exemption Formal request to FDA for IND exemption IND/IDE guide for investigators Investigator-initiated INDs FDA Guidance: Determining whether Human Research Studies Can be Conducted without an IND FDA Guidance on Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings Guidance for Industry IDE Applications Guide to Conducting Clinical Trials at Boston Children’s Hospital FDA Forms (1572, 3454, 3455, 3500A, 3674, 3926) Office of Regulatory Affairs LibGuide IND Protocol Amendments Guidance and Template for Drug Products FDA Guidance Clinical research practice guidelines Assuring Quality in Clinical Research Developing a Manual of Operations Recruitment Plans Research Data Collection Research Staff Training Study Document and Data Handling How to write a protocol Guideline for Developing Pharmacy Procedures for Clinical Trials –RPG-010 Additional guidelines Blood drawing guidelines (IRB site) Additional resources ClinCard Reference Materials IRB Tools, templates and guidelines Investigational Pharmacy Regulatory tools and templates Subject recruitment tools and templates Training and education tools and templates ReGARDD: Regulatory Guidance for Academic Research of Drugs and Devices FDA Guidance for DSMB Data and Safety Monitoring Plan - Sample DSMB Report – Sample Guideline for Developing Case Report Forms (CRFs) Case Report Form (CRF) QC Checklist Clinical Study Tracking Template for DSMB Template Table of Contents for Multi-Site Sponsor Binder Template Table of Contents for Single-Site Sponsor Binder Template Table of Contents for Site Regulatory Binder Draft WorkPlan
Tools, templates, policies & guidelines Templates/Tools Template for documentation of Informed consent discussion Eligibility checklist Meeting agenda template Meeting minutes template PI oversight meeting log Specimen tracking log Staff signature and delegation log Delegation of responsibility grid Telephone contact log Training documentation log DSMB charter template Investigator-initiated protocol templates Regulatory Initial IND application IND annual report Request to BCH for IND exemption Formal request to FDA for IND exemption IND/IDE guide for investigators Investigator-initiated INDs FDA Guidance: Determining whether Human Research Studies Can be Conducted without an IND FDA Guidance on Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings Guidance for Industry IDE Applications Guide to Conducting Clinical Trials at Boston Children’s Hospital FDA Forms (1572, 3454, 3455, 3500A, 3674, 3926) Office of Regulatory Affairs LibGuide IND Protocol Amendments Guidance and Template for Drug Products FDA Guidance Clinical research practice guidelines Assuring Quality in Clinical Research Developing a Manual of Operations Recruitment Plans Research Data Collection Research Staff Training Study Document and Data Handling How to write a protocol Guideline for Developing Pharmacy Procedures for Clinical Trials –RPG-010 Additional guidelines Blood drawing guidelines (IRB site) Additional resources ClinCard Reference Materials IRB Tools, templates and guidelines Investigational Pharmacy Regulatory tools and templates Subject recruitment tools and templates Training and education tools and templates ReGARDD: Regulatory Guidance for Academic Research of Drugs and Devices FDA Guidance for DSMB Data and Safety Monitoring Plan - Sample DSMB Report – Sample Guideline for Developing Case Report Forms (CRFs) Case Report Form (CRF) QC Checklist Clinical Study Tracking Template for DSMB Template Table of Contents for Multi-Site Sponsor Binder Template Table of Contents for Single-Site Sponsor Binder Template Table of Contents for Site Regulatory Binder Draft WorkPlan
