Published by ECRIN
PCOMClinical Trials ToolkitExtension of the SPIRIT (Standard protocol items: recommendations for interventional trials) guideline, SPIRIT PRO provides guidelines for inclusion of patient-reported outcomes in clinical trial protocols.
View this resource Bookmark this resourceThe ERICA Patient Reported Outcome Measures (PROMs) Repository is the first attempt to identify and centralize Clinical Assessment Outcomes questionnaires of relevance for rare diseases and constitutes a milestone in the Europe-wide standardization of Patient-Centered Outcome Measures (PCOMs) and PROMs for rare diseases.
View this resource Bookmark this resourcePublished by ECRINTranspariMED
ToolboxClinical Trials ToolkitCollection of hands-on tools and case studies that universities and other institution can use to improve their registration and reporting of clinical trials.
View this resource Bookmark this resourcePublished by National Institute for Health and Care Research (NIHR)ECRIN
Clinical Trials ToolkitThis guidance summarises what an under-served group is, a roadmap suggesting intervention points to improve inclusion, examples of under-served groups and barriers to inclusion
View this resource Bookmark this resourcePANDA is aimed at trialists and researchers in clinical trials who are keen to learn about adaptive designs, their practical application, potential benefits and limitations. The target audience includes, but is not limited to, trial statisticians, clinicians, health economists, grant proposal developers, trial managers, data managers, and reviewers of grant applications
View this resource Bookmark this resourcePublished by Pediatric musculOskeletal & RheumaTology Innovation COre centerECRIN
Clinical Trials ToolkitToolboxThe toolkit is a curated series of publicly accessible videos and links covering essential operational details that early investigators need to know before embarking on a clinical trial with a special focus on pediatric trials. Topics address study startup, study documents, consent, oversight, management, and safety.
View this resource Bookmark this resourcePublished by ECRINThe Global Health Network
TemplatesClinical Trials ToolkitDeveloped by the Global Health Trials Knowledge Hub , this library of templates includes clinical trials´ general logs and trackers, documents for finances management, patients enrolment and study, site and staff management
View this resource Bookmark this resourcePublished by ECRINGoodtrials
Clinical Trials ToolkitGuidelineThe guidance is intended to support all individuals and organizations involved in the planning, conduct, analysis, oversight, interpretation, funding, and regulation of RCTs of any health intervention for any purpose in any setting.
View this resource Bookmark this resourcePublished by European Medicines Agency (EMA)ECRIN
Clinical Trials ToolkitThe EMA guideline on the content, management and archiving of the TMF provides guidance relating to the media used for storage of documents (including requirements when original records are transferred to electronic media for the purpose of archive).
View this resource Bookmark this resourcePublished by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)ECRIN
Clinical Trials ToolkitThe objective of this guideline is to allow the compilation of a single core clinical study report (CSR) acceptable to all regulatory authorities of the ICH regions
View this resource Bookmark this resource
