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Following are data collection resources used for each CTTI project. These are data collection instruments only and all research was approved by the Duke IRB. More information on each project—including reports of the data, when available in peer-reviewed publications—is available by clicking "Learn More".
Antibacterial Drug Development (ABDD)
- ABDD Peds Trials: Survey of Pediatric Community Health Care Providers
- ABDD Peds Trials: Survey of Pediatric Clinical Trial Investigators
- ABDD Peds Trials: Interview Guide for Parents
- ABDD Unmet Need: Focus Group Discussion Guide for Patients and Caregivers
- ABDD Unmet Need: Interview Guide for Health Care Providers
- ABDD HABP/VABP: Assessment of Perceived Acceptability Interview Questions Supplement
- ABDD HABP/VABP: Patient & Caregiver Demographic Questionnaires
- ABDD HABP/VABP: Delphi Process Interview Questions Supplement
- ABDD HABP/VABP: Risk Factors for HABP/VABP (aka PROPHETIC) Study Data (Data is located on Vivli.org; registration and request submission required to access data)
Learn more about CTTI's ABDD work.
ClinicalTrials.gov Reporting Challenges
- ClinicalTrials.gov Reporting Challenges: Interview Guide for Data Submitters and Oversight Personnel
- ClinicalTrials.gov Reporting Challenges: Survey of Data Submitters and Oversight Personnel
Learn more about CTTI's ClinicalTrials.gov Reporting Challenges work.
Data Monitoring Committees (DMCs)
- DMCs: Focus Group Discussion Guide (Multi-Stakeholder)
- DMCs: Survey of DMC Members and DMC Organizers
Learn more about CTTI's DMC work.
Digital Health Trials (formerly Mobile Clinical Trials, or MCT)
- MCT Decentralized Trials: Legal & Regulatory Interview Guide
- MCT Decentralized Trials: Legal & Regulatory Demographic Questionnaire
- MCT Devices: Demographic Questionnaire - Research Sponsors and Investigators
- MCT Mobile Technologies: Interview Guide for Investigators and Sponsors
- MCT Mobile Technologies: Interview Guide for Device Manufacturers and Data Management Experts
- MCT Stakeholder Perceptions: Interview Guide for Investigative Sites
- MCT Stakeholder Perceptions: Demographic Questionnaire - MCT Stakeholders (Site Investigators)
- MCT Stakeholder Perceptions: Survey of Patients
- MCT Stakeholder Perceptions: Patient Survey Data
Learn more about CTTI's DHT work.
Electronic Healthcare Data
- IMPACT-AFib Focus Group Guide for Healthcare Providers
- IMPACT-AFib Interview Guide for Patients
- IMPACT-AFib Participant Summary: Formative Research Summary
- Demographic Questionnaire - Patients with Atrial Fibrillation
- Atrial Fibrillation - Demographic Questionnaire for Providers
Learn more about CTTI's Electronic Healthcare Data work.
Embedding Clinical Trials into Clinical Practice
- In-Depth Interview Question Guide: Sponsors of Registrational Trials
- In-Depth Interview Question Guide: Sponsors of Non-Registrational Trials
- In-Depth Interview Question Guide: Implementers of Embedded Trials
Learn more about CTTI's Embedding Clinical Trials into Clinical Practice work.
Informed Consent
Learn more about CTTI's Informed Consent work.
Informing ICH E6 Renovation
Learn more about CTTI's Inforning ICH E6 Renovation work.
Investigator Community
- Investigator Community: Investigator Turnover - Barriers & Possible Solutions to Continued Participation
- Investigator Community: Interview Guide for Principal Investigators
Learn more about CTTI's Investigator Community work.
Investigator Qualification
- Investigator Qualification: Investigator and Sponsor Interview Guide
- Investigator Qualification: Demographic Questionnaires - Investigators & Sponsors
Learn more about CTTI's Investigator Qualification work.
Large Simple Trials
Learn more about CTTI's Large Simple Trials work.
Patient Group Engagement (PGE)
- PGE: Interview Guide for Industry, Academia, NIH, and FDA
- PGE Survey: Understanding Interactions Between Patient Groups and Academic and Industry Research Sponsors
- PGE: Interview Guide of Value Assessment of Patient Group Engagement Methods
- PGE: Interview Guide for Sponsors
- PGE: Patient Group Demographic Questionnaire
- PGE: Sponsor Demographic Questionnaire
Learn more about CTTI's PGE work.
Pregnancy Testing
Learn more about CTTI's Pregnancy Testing work.
Quality by Design (QbD)
Learn more about CTTI's QbD work.
Recruitment
Learn more about CTTI's Recruitment work.
Real-World Data (RWD)
Learn more about CTTI's RWD work.
Registry Trials
Learn more about CTTI's Registry Trials work.
Safety Reporting
- Safety Reporting: Interview Guide for Investigators
- Safety Reporting: Survey of Sponsors
- Safety Reporting: Survey of Investigators
- Safety Reporting: Interview Guide for Sponsors
Learn more about CTTI's Safety Reporting work.
Single IRB
- Single IRB: Interview Guide (Multi-Stakeholder)
- Single IRB: Question Guide for Industry and Trade Organization Representatives
- Single IRB: Question Guide for Investigators
- Single IRB: Question Guide for IRB Members
- Single IRB: Question Guide for Regulatory Administrators and Study Coordinators
- Single IRB: Industry and Trade Representatives - Demographic Questions
- Single IRB: Investigators - Demographic Questions
- Single IRB: IRB Members - Demographic Questions
- Single IRB: Regulatory Administrators - Study Coordinators - Demographic Questions
- Single IRB: sIRB Question Guide - IRB Chairs and Administrators Only and IRB Leadership
- Single IRB: sIRB Question Guide - IRB Representatives Other Than IRB Chairs and Administrators Only
- Single IRB: sIRB Question Guide - Investigators and Study Coordinators
- Single IRB: Screening-Demographic Questionnaire 360 CSI
- Single IRB: Demographic Questionnaire - Research Administration Leadership
Learn more about CTTI's sIRB work.