eCRF Database

The KCTU has hosted a commercial data entry system (InferMed MACRO) since 2005. The system is compliant with FDA 21 CFR part 11 and Good Clinical Practice (GCP).

It is an appropriate system to use for medicinal trials falling under the Medicines for Human Use (Clinical Trials) Regulations 2004 and its subsequent amendments, and has also been used for other complex intervention trials. The web based system can be accessed 24 hours a day.

Find out more

To find out more about the KCTU Database services, download this flyer.
To request a data extract from a Macro eCRF Database, complete
this form.

 

Functionality

Roles can be assigned to users, giving the ability to enter data relating to participants or to view data and raise discrepancies, but not amend data. Roles can also be tailored to be blind to treatment allocation where appropriate, with a secondary database being programmed to collect information about therapy sessions or surgical interventions, for example.

The system can be programmed to perform validation checks, such as range checks to prevent data entry errors. Missing data codes are routinely programmed into all fields, for ease of analysis. The system can also be programmed to flag up when a missing data code is entered, to aid monitoring. The system can also be programmed to include e-signatures, where this is required.  A standard feature of InferMed MACRO data entry system is the built in audit trail on all data fields, the automatic saving of data as you leave a form, and the ability to maintain a record of ‘source data verification’ checks. The system also has formal database lock functionality. 

Package Costs

The cost calculation of programming and hosting a data entry system for a study depends on the number of unique data variables to be programmed, the number of study sites, the number of users and variety of access required, the duration of time the system needs to be ‘live’ and the expected number of data extract requests required for data cleaning, data monitoring committee and trial steering committee reports during the study. 

 

Bronze service

Single site study
UK based

£3,500 database setup
£1,100 server storage space (2 years)
£600 administration of passwords/year (2 years)
£110 per export (4 exports)
Total cost = £7,340

  • Single data entry user assigned
  • Single monitor assigned
  • Database live for up to 24 months
  • Single database programmed
  • Pre-programmed adverse event form used
  • Pre-programmed concomitant medication form used
  • Pre-programmed medical history form used
  • Template inclusion/exclusion form used
  • Up to 100 additional unique variables programmed
  • Study site to enter their data online

Silver service

Multicentre study
UK based

£35 per unique variable programmed*
£150 annual data entry site license
£1,100 server storage space/year
£600 administration/year
£600 surcharge per extra database 
£110 per data extract**

Total cost = £18,000-£40,000

  • Multiple data entry users assigned
  • Multiple monitors assigned
  • Up to 500 unique variables programmed
  • Non-commercial data entry license fees apply
  • Study sites to enter their data online
  • Up to three databases programmed:
    1. baseline and outcome data
    2. intervention details
    3. therapist details

Gold service

Multinational trial
EU based

  • quotes available on a case by case basis following discussion with KCTU

Platinum service

Multinational trial
beyond EU

  • quotes available on a case by case basis following discussion with KCTU

*The average RCT requires 500 unique variables and **at least 2 data extracts per year.