Table 3 Time required to prepare the data pack for the MENDS trial
Step of process | Role | Tasks | Time (hours) |
|---|---|---|---|
Getting access to the data and documentation | Statistician | • Requesting access • Understanding layout of datasets and format • Understanding how to extract into SAS (statistician had not used these systems before) | 1.5 |
Information systems | • Setting up access to SQL server tables • Setting up access to MACRO data • Providing documentation about the tables, questions groups and visits • Providing documentation of the visit schedule • Providing a list of variables in MACRO • Providing details of logins and website access MACRO | 6 | |
De-identification | Statistician | • First stage of anonymisation (IDs, PII and dates), preparation of variable list and identification of free-text variables • Second stage of anonymisation: redaction of free text, generation of aggregated tables and preparation of variable list. • Judgements had to be made regarding what could be redacted and variables kept, redacted and tabulated or redacted completely. Further redaction may be needed where times of year are referred to in free text (e.g. Christmas, Easter). | 26 |
Final data pack | Statistician | • Pull all relevant files and documentation together and transfer to separate secure folder | 1 |
Quality control check | Statistician | • Independent statistician to check the datasets to ensure that relevant data have been anonymised and check any remaining text variables are suitably redacted to protect patient privacy | 5 |
Total | Statistician | 33.5 | |
Information systems | 6 | ||
Overall | 39.5 | ||