Where possible, make reference to any outcome measures which you used to objectively demonstrate how the patients condition evolved through the course of management. Discussion: Synthesize the foregoing subsections and explain both correlations and apparent inconsistencies. Immunogenicity report, if applicable 14. List of references (abstracts or manuscripts) from publications derived from clinical study data 15. PDF files of all medical literature supporting the study and cited in the CSR 16. Names and addresses of CROs used and description of their role in the study, if applicable 16. Sponsors content- or process-related SOPs that apply to writing clinical study reports 17. Description of sponsors ideal label for the investigational drug product (optional) 18. List of names and contact information of sponsors personnel who participated in the clinical study: medical monitor (usually an MD biostatistician, and clinical research associate(s) This list is a reflection of my experience directing medical writing departments and doing medical writing since 1995. Screening logs for subject disposition (if not provided in TLFs) 3. Case report forms (CRFs) of subjects who had serious adverse events (SAEs) 4. Milestone study period dates: dates when first subject enrolled, last subject enrolled, and last subject completed study 5.
This leads to frustration and causes delays in the CSRs development. In turn, delayed CSR completion can extend the actual submission date of the products eCTD/marketing application-because CSRs are required content. Contract medical writers sometimes find themselves hired to write a clinical study report (CSR) (or clinical trial report (CTR) before their client has prepared all of the information needed for the report.