preparation of the study/trial/research report

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Note added at 37 mins (2020-03-02 16:24:32 GMT)
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http://www.fao.org/3/s4862e/s4862e04.htm
3. PREPARATION OF THE STUDY REPORT

https://onlinelibrary.wiley.com/doi/10.1002/9781118873922.ch...
This chapter provides guidance for managing the beginning and the end of a nonclinical study, including the development and management of the study protocol and data interpretation and reporting after the study.

https://www.triga-s.de/en/project-management/
PROJECT MANAGEMENT
Documentation:

Study Protocol development according to the regulatory requirements / DIN 14155 and DIN 13612
Preparation of investigator contracts
Creation of Case Report Forms (CRFs, eCRF) and Patient Information / Declarations of Consent
Compilation of documentation, application and submission to the responsible ethics commissions and authorities
Implementation and preparation of publications
Documentation of the clinical data and preparation of the study report according to GCP / ICH
Documentation of the laboratory values according to GCP and GCLP