Skip to main content

Table 1 Operational and data management considerations and solutions

From: Overcoming challenges to data quality in the ASPREE clinical trial

Operational domain

Key requirements

Design solution

Visit booking

 - Identification of participants to be booked and the visit required

 - Organisation of “due” participants by visit venue

 - Computation of visit venue booking time

 - Recording and tracking of venue room bookings

 - Recording tracking of participants bookings linked with room bookings

“2 step” solution implemented

 - Venue room booking information entered via a single web page

 - Participants’ booking information entered on a nested web page

Bookings presented in both calendar and list format via the web application

Conduct of calls

 - Identification of participants to be contacted

 - Mechanism to record call attempts and messages

 - Mechanism to record if participants are unavailable for calls at certain timepoints

Online call tracking implemented

 - List of participants due and eligible to receive calls available via web application

Simple online phone call data collection form

Study medication tracking

 - Tracking of dispensing and retrieval of study medication bottle

 - Mechanism to ensure that the correct medication is provided to each participant

Online drug log implemented

 - Study medication bottle dispensation date and retrieval date recorded

 - Pill count logged

To avoid unnecessary queries caused by transcription errors, each participant’s unique study medication code prompted and validated on data entry

Retention

 - Conduct of scheduled contact at certain timepoints identified as increasing the risk of participant withdrawal (e.g. between dementia trigger and completion of additional cognitive assessment)

 - Mechanism required to shift participants at risk of withdrawal from the regular contact lists to a retention team list

Retention status implemented

 - Database “views” utilised to derive a status describing whether scheduled study contact was appropriate (e.g. not eligible for phone contact – dementia trigger follow up in progress)

Status utilised to shift participants from regular contact lists to retention team lists

Communication

 - Mechanism for staff to notify PCPs/GPs of abnormal results

 - Mechanism for requesting clinical documents from third parties (e.g. hospitals, specialists and general practitioners)

Curated third party communication pipeline created and implemented

 - Standard document request and abnormal result notification letters auto-populated with relevant participant details via web application

 - Microsoft Visual Basic for Applications utilised to send standard letters via fax or email communications

Staff decision support

 - Mechanism to ensure that protocol specified follow up of endpoints was completed

 - Mechanism to ensure protocol specified follow up of abnormal results was completed

 - Mechanism to ensure that only eligible participants were randomised

Key operational “status” for each study participant or key step derived and displayed

 - Database views utilised to derive a status describing the operational “next step”’ (e.g. event coded – awaiting supporting documents; annual visit – overdue etc)

Status displayed on relevant pages on the user interface

Randomisation restrictions implemented

 - Automated checks compared entered data against eligibility criteria

 - Randomisation function disabled for ineligible participants

Data entry

 - Mechanism to alert staff to potentially incorrect data for review

 - Clear process for alerting staff to data queries for resolution

Checks and balances implemented to minimise transcription errors

 - Pre-programmed value ranges, process prompts and protocol compliance checks, checked at the point of data entry

 - Page submission restrictions implemented to check for logic between values on a page

Staff action list implemented

 - Automated checks compared entered data against acceptable rangesa and produced “action items”

 - Staff specific list of action items displayed on “home” page of AWARD-Data web application

  1. PCP primary care provider, GP general practitioner
  2. aAcceptable ranges were determined by an expert committee based on physiological plausibility