This list of clincal data management documentation is to ensure standardized and adequate archival of trial documents and records in clinical data management, which is applicable to all of phase I-IV clinical trials.

Objective The change of thyroid hormones affects male sexual function, but the underlying physiological mechanism is not yet clear.The aim of this study was to explore the association of thyroid hormones with abnormal penile neuro-electrophysiology in patients with premature ejaculation (PE).Methods This retrospective study included 52 acquired PE (APE) patients aged 35.36 ± 8.39 years and 24 healthy males aged 32.87±7.45 years.We measured the levels of thyroid hormones in all the subjects and, based on the latency time of penile sympathetic skin responses (PSSR), classified the APE patients into a normal (n=31) and an abnormal PSSR type (n=31).Results The concentration of total tetraiodothyronine (TT4) in the serum was significantly higher in the APE patients than in the normal control ([102.81±18.37] vs [92.68±11.56] nmol/L, P=0.018).The levels of serum TT4 and free tetraiodothyronine (FT4) were both markedly increased in the APE patients of the abnormal PSSR type as compared with those of the normal PSSR type ([113.28±20.89] vs [95.72±12.42] nmol/L, P<0.001 and [12.02±0.88] vs [10.81±1.63] nmol/L, P=0.003).The FT4 concentration was correlated negatively with the latency time of PSSR (r=-0.363, P=0.008) and positively with the Premature Ejaculation Diagnostic Tool (PEDT) scores (r=0.455, P=0.001).Conclusion Abnormal PSSR may be associated with elevated levels of thyroid hormones in APE patients, and regulation of thyroid hormone levels may help improve the symptoms of PE with abnormal PSSR.