List of Guidances for Statistics in Regulatory Affairs
This List presents a comprehensive source of references for statistical guidance documents and related articles that are relevant to regulatory affairs for those statisticians that work on clinical studies. The List is associated with the Wikipedia page Guidances for statistics in regulatory affairs that aims to address the various topics of the listed guidances. Regulatory guidances (draft and/or final ) are subject to revisions. Therefore, users of the guidances are advised to consult the original website to check for the latest version. Users are also encouraged to update the Wikipedia List. References classified by statistical topic Good clinical practice ICH E6(R2): Good clinical practice is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. FDA: Good Review Practice: Clinical Review of Investigational New Drug Applications. This good review practice (GRP) document was prepared to assist FDA clinical review staff in reviewing clinical submissions to an investigational new drug application (IND) from the pre-IND phase to the time of the pre-new drug application/biologics license application meeting. Data monitoring committees CHMP/EWP/5872/03: Data monitoring committees (EMA) deals with independent data monitoring committees. It highlights the key issues involved when sponsors include