Step of process | Role | Tasks | Time (hours) |
---|---|---|---|
Getting access to the data and documentation | Statistician | • Requesting access and liaising with TM and IS • Accessing secure folder to open datasets (some problems encountered when trying to access shared folder) • Establishing relevant data tables e.g. table summarising payments made to GPs would not be relevant • Setting up secure shared folder | 2.5 |
Information systems | • Working out how to open Access database (old version) • Exporting tables from Access database to SAS | 3 | |
Trial manager | • Locating data files and documentation • Transferring to secure shared drive • Scanning blank CRFs and paper copy of the blank quality-of-life patient questionnaire | 5 | |
De-identification | Statistician | • First stage of de-identification (IDs, personally identifiable information and dates), preparation of variable list and identification of free-text variables • Second stage of de-identification: redaction of free text, generation of aggregated tables and preparation of variable list. Judgements made regarding what could be redacted and variables kept, redacted and tabulated or redacted completely | 32 |
Final data pack | Statistician | • Pull all relevant files and documentation together and transfer to separate secure folder | 1.5 |
Quality control check | Statistician | • Independent statistician to understand the datasets and check through to ensure that relevant data have been de-identified and check any remaining text variables are suitably redacted to protect patient privacy | 6 |
Total | Statistician | 42 | |
Information systems | 3 | ||
Trial manager | 5 | ||
Overall | 50 |