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Solutions Available in Additional Languages

This page is dedicated to sharing some of our assets translated into local languages with the broader global community for potential use.

BY ACCESSING AND USING ANY OF THE TRANSLATED DELIVERABLES, YOU ACKNOWLEDGE THAT YOU AGREE TO BE BOUND BY THE BELOW TERMS.  IF YOU DO NOT AGREE TO THESE TERMS, THEN YOU SHOULD NOT ACCESS OR USE ANY TRANSLATED DELIVERABLE:  The documents available via the links below are translations of TransCelerate deliverables, which were originally written in English. In the event of any conflict between a translated document and an original document, the documents in the original language take precedence.  TransCelerate did not prepare these translations but has permission to make them available to the public and does so merely as a courtesy, for informational purposes only. In certain instances, TransCelerate might from time to time receive reports or claims that the language in various translations may be inaccurately or improperly worded.  Any person or company using any translation assumes all risks associated with using the particular translation.  On behalf of itself and its members, TransCelerate disclaims any responsibility or liability for any loss of any kind resulting from the use of any translation provided by TransCelerate, for any indirect or consequential, speculative, remote, punitive or exemplary damages, loss whatsoever to any person or company using any of the translations, whether arising out of or as result of breach of contract, warranty, tort (including negligence), strict liability or otherwise arising from, relating to or in connection with the translated deliverables. The translations posted on this webpage or anywhere on TransCelerate’s website are provided ‘as is’ without warranty of any kind, either expressed or implied, including, but not limited to, the implied warranties of fitness for a particular purpose, non-infringement, or merchantability. These translations, and all claims or causes of action (whether in contract, tort,  or statute) that may be based upon, arise out of or relate to these translations, shall be governed by,  and enforced in accordance with, the laws of the State of Delaware U.S.A.,  including its statutes of limitations.

Common Protocol Template
Form Title
Description
Available Languages

Basic Word Edition Core Template

MS Word basic edition of the Common Protocol Template comprised of a common heading structure, harmonized content, and supporting instructional text for authors.

Patient Library

Contains content pertinent to studies in patients.

Site Qualification & Training
Form Title
Description
Available Languages

Form FDA 1572 – Guidance for Completion

Intends to assist sites with the interpretation of FDA’s 1571/1572 forms and guidance.

Financial Disclosure Form (FIDS)

Form intended for use by Clinical Investigators to disclose their financial interests for the period of time he or she participated in the study and for one year following the end of his or her participation in the study (as required by the U.S. Code of Federal Regulations 21CFR54) to the Study Sponsor.

Facility Profile Form

A questionnaire for collecting site capability information (off-line version of form inside Shared Investigator Platform).

For reference only – please complete the forms in English, whether  uploading to the Shared Investigator Platform or submitting to the sponsor as an offline form.

Facility Profile Form Guidance

Overview of the intention of the facility profile form.

Facility Profile Form FAQs

Most frequently asked questions around the facility profile form.

Principal Investigator Oversight Informational Program

Informational program outlining the basic components related to Principal Investigator oversight of clinical trials.

Adverse Events and Safety

Explains and defines an Adverse Event. Describes the Investigator’s role and responsibilities regarding Subject Safety and reporting requirements for Serious Adverse Events.

Clinical Research Overview

Introduces and describes the phases of a Clinical Research Study and the various study designs.

Clinical Practice vs Clinical Research

An overview of the differences between the activities which occur when managing patients during routine Clinical Practice versus the activities when you are managing subjects as part of a Clinical Research Study.

Conducting a Study

Explains the three stages of study conduct phases including the subject enrollment/recruitment period, the ongoing maintenance and the subject exit/completion phase including the tasks and activities associated with these stages.

IRB/IEC Responsibilities and Informed Consent

Overview of the purpose and activities of the IRB/IEC and the Investigator’s responsibilities in accordance with ICH-GCP. Describes the process of informed consent and the responsibilities of the Investigator when obtaining informed consent.

Delegation and Training

An overview of study task delegation and the importance of providing/documents study training for site staff.

Source Documentation

A review of the terms source data and source documents. Describes the key attributes of source documents, the intent of ALCOA and CCEA and describes the appropriate processes for creating, maintaining and storing source documents.

Investigational Product

Overview of the basics of Investigational Product management and use during a clinical trial. Topics include inventory and temperature control and recommendations for source documentation.

Essential Documents for a Clinical Study

Describes the requirements for Clinical Study essential documents. Describes the type of essential documents collected for a Clinical Study during the different study phases.

Facilities and Equipment

Describes the equipment and resourcing needs of a research center.

Monitoring and Auditing

Describes the routine monitoring and auditing activities which occur during a clinical study. This topic includes information on the purpose, what to expect, and tips to prepare for these Sponsor activities.

Quality Management System
Form Title
Description
Available Languages

Clinical QMS Concept Paper- From Vision to Conceptual Framework

Chronicles the evolution of a TransCelerate paper on the conceptual Clinical QMS framework, and helps readers understand global clinical trial stakeholder perspective.

Issue Management Manuscript

Assists clinical development organizations in understanding the benefits and basic components of an issue management system.

Patient Experience
Form Title
Description
Available Languages

Patient Protocol Engagement Toolkit (P-PET) User Guide Version 1.5

The Patient Protocol Engagement Toolkit User Guide supports sponsors in (1) understanding the value of implementing the P-PET in their respective clinical studies including considerations for engaging in a virtual environment, (2) understanding how to leverage the P-PET and implement it in a clinical study and share ideas and best practices on how to have meaningful discussions with patients, (3) socializing with stakeholders to seek greater support as needed and (4) providing example case studies.

Patient Protocol Engagement Toolkit (P-PET) Resource Guide Version 1.5

The Patient Protocol Engagement Toolkit (P-PET) Resource Guide provides a set of sample questions for consideration during the patient engagement. Examples of visual aids are also included to facilitate clear communication of study design and protocol-related concepts to patients.

P-PET PAB Sample Template

Template to help support engagement discussions with patients/Patient Advisory Boards (PAB).

P-PET PAB Thank You Note: Sample Template

Template to help support engagement discussions with patients/Patient Advisory Boards (PAB).

P-PET PAB Satisfaction Survey: Patient Advisor Template

Template to help support engagement discussions with patients/Patient Advisory Boards (PAB).

P-PET PAB Patient Advisor Report Template

Template to help support engagement discussions with study teams.

Study Participant Feedback Questionnaire (SPFQ) Socialization Presentation

Inform key stakeholders within your organization of the value of using the SPFQ in your clinical studies. The socialization deck offers customizable materials providing an introduction to the SPFQ and how it may improve patient centricity in your studies.

Study Participant Feedback Questionnaire (SPFQ) Implementation User Guide

The SPFQ Implementation User Guide is intended to support each sponsor company’s customization and implementation of the SPFQ.

Study Participant Feedback Questionnaire (SPFQ)

The SPFQ is a set of three brief patient questionnaires designed to capture patients’ experiences at the beginning, during, and end of each clinical study, independent of disease and treatment.

Study Participant Feedback Questionnaire (SPFQ)

The SPFQ is a set of three brief patient questionnaires designed to capture patients’ experiences at the beginning, during, and end of each clinical study, independent of disease and treatment.

Study Participant Feedback Questionnaire (SPFQ)

The SPFQ is a set of three brief patient questionnaires designed to capture patients’ experiences at the beginning, during, and end of each clinical study, independent of disease and treatment.

Study Participant Feedback Questionnaire (SPFQ)

The SPFQ is a set of three brief patient questionnaires designed to capture patients’ experiences at the beginning, during, and end of each clinical study, independent of disease and treatment.

Study Participant Feedback Questionnaire (SPFQ)

The SPFQ is a set of three brief patient questionnaires designed to capture patients’ experiences at the beginning, during, and end of each clinical study, independent of disease and treatment.

Study Participant Feedback Questionnaire (SPFQ)

The SPFQ is a set of three brief patient questionnaires designed to capture patients’ experiences at the beginning, during, and end of each clinical study, independent of disease and treatment.

Study Participant Feedback Questionnaire (SPFQ)

The SPFQ is a set of three brief patient questionnaires designed to capture patients’ experiences at the beginning, during, and end of each clinical study, independent of disease and treatment.

Study Participant Feedback Questionnaire (SPFQ)

The SPFQ is a set of three brief patient questionnaires designed to capture patients’ experiences at the beginning, during, and end of each clinical study, independent of disease and treatment.

Study Participant Feedback Questionnaire (SPFQ)

The SPFQ is a set of three brief patient questionnaires designed to capture patients’ experiences at the beginning, during, and end of each clinical study, independent of disease and treatment.

Study Participant Feedback Questionnaire (SPFQ)

The SPFQ is a set of three brief patient questionnaires designed to capture patients’ experiences at the beginning, during, and end of each clinical study, independent of disease and treatment.

Study Participant Feedback Questionnaire (SPFQ)

The SPFQ is a set of three brief patient questionnaires designed to capture patients’ experiences at the beginning, during, and end of each clinical study, independent of disease and treatment.

Study Participant Feedback Questionnaire (SPFQ)

The SPFQ is a set of three brief patient questionnaires designed to capture patients’ experiences at the beginning, during, and end of each clinical study, independent of disease and treatment.

Study Participant Feedback Questionnaire (SPFQ)

The SPFQ is a set of three brief patient questionnaires designed to capture patients’ experiences at the beginning, during, and end of each clinical study, independent of disease and treatment.

Study Participant Feedback Questionnaire (SPFQ)

The SPFQ is a set of three brief patient questionnaires designed to capture patients’ experiences at the beginning, during, and end of each clinical study, independent of disease and treatment.

Study Participant Feedback Questionnaire (SPFQ)

The SPFQ is a set of three brief patient questionnaires designed to capture patients’ experiences at the beginning, during, and end of each clinical study, independent of disease and treatment.

Study Participant Feedback Questionnaire (SPFQ)

The SPFQ is a set of three brief patient questionnaires designed to capture patients’ experiences at the beginning, during, and end of each clinical study, independent of disease and treatment.

Study Participant Feedback Questionnaire (SPFQ)

The SPFQ is a set of three brief patient questionnaires designed to capture patients’ experiences at the beginning, during, and end of each clinical study, independent of disease and treatment.

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