Data entry methods

Aim

To choose an efficient method and corresponding  computer program for data entry (including online data collection), taking into consideration the types of data, research population,  risk of data entry errors, research processes, privacy, (GCP) regulations and the necessary time investment for both the creation of the entry screen as well as the data entry. This guidelines only applies to quantitative research and not qualitative research.

 

Requirements

  • Choose the most efficient method and corresponding computer program (or custom made solution) given the study design, data collection methods, data types, quality, usability and regulations.
  • Make maximum use of the standard programmes offered by the Data Management department.
  • The advice is if possible to make maximum use of online data collection tools. This saves data entry time and the quality of the data is in generally also better, for example by a proper routing and required variables in a digital questionnaire.
  • Make in the event of WMO / GCP required research for the (e) CRFs mandatory use of a certified Clinical (Trial) Data Management System.

 

Documentation

  • Describe the chosen data entry method(s) and the associated program(s) or custom made solution(s).
  • Describe the reason when there is any deviation from the standard software offered by the Data Management department.
  • Notice: In the case of WMO / GCP required research and when Case Report Forms are being used you are required to make use of a certified Clinical Data Management System. From such a system used, the following information must be recorded in the data management plan:
    • Information about the validation of the system in accordance to 21 CFR Part 11 compliance
    • Information about security aspects, including database and server
    • Information about Backup and Recovery procedures
    • Information about the Audit trail
    • Information about the validation of the electronic signature
    • Information about the logging procedure
    • Information about the hostingprovider

 

Responsibilities

Executing researcher: To consider different data entry methods and choose together with the project leader.
Project leaders: To advise the investigator to choose highly efficient and reliable methods and computer programs for data entry and designing data entry screens.
Research assistant: N.a.

 

How To

In most instances research data will need to be entered before the data can be analysed. There are various methods of data import at the EMGO, with associated computer programmes, available for this task.
Programmes for creating internet questionnaires:
  1. Netquestionnaires;
Programmes for creating forms for manual data entry of questionnaires or registration forms on paper
  1. Blaise, Castor
  2. SPSS data editor: for just a limited number of variables (and only for not WMO and GCP compliant research).
Programmes for creating forms for conducting face-to-face and telephone interviews
  1. Blaise
Programmes to conduct Clinical Trials and built Electronic Case Report Forms under the strict conditions  of Good Clinical Practice
  1. Castor, a webbased Clinical Data Management System
  2. OpenClinica, a webbased Clinical Data Management System
Please note that not all programs are to use free of charge for EMGO researchers outside the VUmc.
Please note also that it is not permitted to store any contact information like names of research participants and other privacy sensitive data in these programs.
Sometimes it is not possible to make use of the offered standard software and is to be built a custom made software solution. For more information and outsourcing a custom made software solution you can contact the Data Management department.
We advise to outsource the creation of web-based questionnaires or input systems for manual data input to the EMGO Institute Data Management department (please refer to the information analysis guideline for more information about outsourcing).
Manual input is usually selected if questionnaires contain a significant number of open questions, or if the data needs to be processed during input or relationships with other databases need to be established during input, for instance, a link to a database containing all of the medicines.
Each input screen being created needs to be in line with the specifications in the codebook. As many controls will be added to the input screen as possible, to prevent non-admissible values and inconsistencies. Variables that do not need to be entered, because they are based on scores from previously entered variables, will be automatically skipped using “skip and fill” rules. So-called “not applicable” codes will be added to these as well.
During the information analysis there will be an extensive evaluation to select the most efficient input method and associated programme. Please contact the Data Management department for more information and advice about the best choice for entering your data.

 

Appendices/references/links

 

Audit questions

  1. Has the most efficient method been selected, given the research population and nature of the data?
  2. Has a standard EMGO programme been used for the data input?
    1. If not, why not?
  3. Have the data been stored in the underlying database in line with the specifications in the code book?

 

V4.0: 2 December 2016: Updated based on current standards and processes
V3.0: 12 May 2015: Revision format
V2.1: 1 Jan 2010: English translation
V2.0: 27 May 2009: Updated based on current standards and processes
V1.1: 19 Oct 2006: Update