analyses and Pooled Analyses Clause Samples
The 'analyses and Pooled Analyses' clause defines how data from multiple studies or sources may be combined and analyzed collectively. In practice, this clause outlines the procedures, permissions, and limitations for aggregating data sets, such as combining results from several clinical trials to increase statistical power or identify broader trends. Its core function is to ensure that all parties understand the conditions under which pooled analyses can occur, thereby promoting transparency and consistency in data interpretation while addressing concerns about data integrity and comparability.
analyses and Pooled Analyses. The following principles apply to research that uses data from more than one previously conducted clinical study (Meta-analyses and Pooled Analyses): · Research utilizing data from the Parties’ previous clinical studies in a manner inconsistent with, or beyond the scope of, the original informed consent requires re-consent of the subjects, or if this is not practical, IRB/IEC approval. If this is not practical, the data are anonymized · The Parties review, before submission for publication, any proposed manuscripts, presentations or abstracts prepared by research collaborators which originate from the Parties human subject research studies (including the Parties supported studies)
analyses and Pooled Analyses. The following principles apply to research that uses data from more than one previously conducted clinical study (Meta-analyses and Pooled Analyses):
analyses and Pooled Analyses. The following principles apply to research that uses data from more than one previously conducted clinical study (Meta-analyses and Pooled Analyses): · Research utilizing data from the Parties’ previous clinical studies in a manner inconsistent with, or beyond the scope of, the original informed consent requires re-consent of the subjects, or if this is not practical, IRB/IEC approval. If this is not practical, the data are anonymized · The Parties review, before submission for publication, any proposed manuscripts, presentations or abstracts prepared by research collaborators which originate from the Parties human subject research studies (including the Parties supported studies) The following principles apply to Non-interventional (observational) human subject research: · For observational studies where clinical data are collected by or on behalf of the Parties specifically for the purpose of the research, the Parties abide by the local legal requirements and regulations for informed consent for the use of these data and IRB/IECs approval is obtained · For observational studies using healthcare databases, the Parties are assured that there is compliance with relevant legal requirements for data privacy and that patients have provided informed consent for the use of their data in research, or IRB/IEC approval has been obtained for that use; or other measures to protect privacy are in place (e.g. the data are anonymized)