Table 1.

Standard documents supplied by Rare Diseases Data Registry of Japan

① Protocol

② Written consent form

③ Database construction definitions

④ Database construction definition guideline

⑤ Case report form

⑥ Statistical analysis plan

⑦ Examples of form templates

⑧ Standard operating procedures for implementing research

⑨ Version management procedures for research‐related documents

⑩ Standard operating procedures for data management

⑪ Standard operating procedures for system construction and management

⑫ Standard operating procedures for monitoring and auditing procedures

⑬ Manual for collection of samples and data

⑭ Manual for data input to electric data capture