This page is dedicated to sharing some of our assets translated* into local languages with the broader global community for potential use. TransCelerate’s Member Companies drive the decisions around what will be translated based on feedback they are receiving within local geographies.
Basic Word Edition Core Template
MS Word enabled format and content template for the protocol, containing a common heading structure, common text, suggested text, and all CPT libraries. Includes a prerequisite analyzer to assess the environment prior to installation. Requires installation of template and add-ins on your workstation.
Contains content pertinent to studies in patients
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.
Site Profile Form
A questionnaire, or “Site Profile Form,” for collecting site capability information.
— Site Profile Form Guidance
Overview of the intention of the site profile form.
— Site Profile Form FAQs
Most frequently asked questions around the site 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.
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.
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.
*The documents above are translations of TransCelerate deliverables which were originally developed in English. TransCelerate did not prepare the translations, nor has it verified the accuracy or word usage included. TransCelerate therefore disclaims any responsibility for any lack of accuracy, clarity or incorrect word usage contained in these assets.