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Table 2 Time required to prepare the data pack for the SANAD trial

From: Resource implications of preparing individual participant data from a clinical trial to share with external researchers

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

  1. TM trial manager, IS information systems, GP General Practitioner, CRF case report form