Zika Virus Case Report Forms

Portuguese | Spanish | French

The following research tools have been developed by an international collaborative effort led by ISARIC, an international consortium that aims to support rapid research during new and emerging disease outbreaks.

The following CRFs are presented as high quality tools to enable researchers and clinicians studying Zika infection to capture a standardised, minimal core dataset. This core dataset reflects the research priorities of highest concern in regards to understanding Zika virus infection, and will allow data to be combined from multiple studies. The CRFs have undergone a peer review process by a panel of expert reviewers with Terms of Reference. Here, they are made available for colleagues to download and adapt for their own purposes (e.g. prospective cohort studies or case control studies) and local regulatory approval.

The key documents required for a clinical research study are a protocol, case report forms (CRFs) to capture the data, and an informed consent form. We are currently working to develop and provide a Zika Clinical Characterisation Protocol (CCP) and informed consent forms to complete this research toolkit.

Zika Virus research tools – at a glance (please scroll down the page to download the documents)

● = Case Report Form (CRF) available

DD = data dictionary available

NOTE: This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

Change log and updates

09 March 2017 | Data Dictionaries v5.8 added

The Data Dictionaries v5.8 are now available to download.

22 December 2016 | Child 0-5 Years v2.0, Adult and Child >5 Years v2.1 and Returning Traveller v3.0 CRFs added

The Child 0-5 Years, Adult and Child >5 Years and Returning Traveller CRFs are now available to download.

07 December 2016 | Epidemiology and Demographics v4.1 added

The Epidemiology and Demographics CRF v4.1 is now available to download.

30 November 2016 | CRFs v6.1 summary of changes from v5.4

All Maternal and Neonatal CRFs v6.1 have been reviewed and updated in all data fields, incorporating suggestions from a diverse group of investigators using the CRFs; these include:

• In all maternal and neonatal CRF modules the introduction has been updated, some new data fields have been included and other questions have been modified or reordered to improve clarity and facilitate collection of information.
• The neonatal baseline and outcome CRF has more detailed data collection fields for measurements, birth abnormalities, baseline observations, and other minor changes across all sections.
• In the neonatal laboratory results CRF and maternal laboratory results CRF, all questions have been reorganised to facilitate collection of information from laboratory results and other examinations and tests.
• Completion guidelines for this version of the CRFs are currently under review and these will be up loaded here in due course.
• The CRFs v6.1 will be translated into Portuguese, Spanish and French in due course.

On-going Review:

Zika Protocol review by WHO

The Zika Clinical Characterisation Protocol continues to be worked on by WHO, ISARIC and IDAMS staff. This will be the 7^th study of the WHO portfolio. The currently available study protocols are available at http://www.who.int/reproductivehealth/zika/zika-virus-research-agenda/en/

16 May 2016 and 02 June 2016 | Version 5.4

The above CRFs will start to be available at the end of December 2016 and end of January 2017

Updates:

• All CRFs have been given an identification number and all their titles have short identifier capitals. For example the maternal baseline and outcome is number [1] with a short code MBO, the neonate baseline and outcome is number [2] with code NBO. This is explained on the first page of all CRFs
• All CRF questions are numbered for easy identification of the data fields
• The CRF [2] neonate baseline and outcome –NBO includes new data fields, please see version with highlighted changes for easy identification from previous version: download CRFs with highlighted changes.
• There is an additional CRF to the neonate baseline and outcome. 
• Portuguese translations available: download zip (word)   download zip (pdf)
• French and Spanish translations are in progress and will be available shortly
• The database will be available in a few weeks and will be open to be used by any investigators who wish to do so.

22 April 2016 | Version 5.3

Updates:

• This new version includes the REACTing logo in all CRFs as we are aligning with them, and asks about mouth ulcers in maternal acute symptoms. The changes in the other languages (CRFs) will follow.

These CRFs will be kept under regular review, and may be modified and updated by ISARIC collaborators as further clinical evidence emerges. They will be submitted to the WHO Ethical Review Board for consideration as a WHO research tool. 

24 March 2016 | Version 5.2 (zip - changes highlighted)

Updates:

• Minor changes to ensure that no data field is left blank
• Implemented changes recommended by French collaborators in all versions (English, Spanish & Portuguese)
• Spanish translations available here
• French translations available: download zip

Under Development:

• Corresponding data dictionaries are currently in development and will be posted here as soon as they are finalized.
• Portuguese translations
• Electronic data storage platform through collaboration with MedSciNet 

29 February 2016 | Version 5.1 (zip)

Updates:

• Major formatting issues were resolved. Word documents are available in order to adapt and translate the CRFs, however, there may be issues between macs and PCs. The PDF format is also available, which should be well formatted on both types of machines

Under Development:

• Corresponding data dictionaries are currently in development and will be posted here as soon as they are finalized.
• Spanish, Portuguese and French translations
• We are currently working on a returning travellers CRF and a clinical characterisation protocol

27 February 2016 | Version 5.0 (zip)

Updates:

• Thank you for your patience while the CRFs were undergoing further revisions, particularly the obstetric data fields. Whilst doing so, we also revised our peer review process and introduced Terms of Reference for a core group of expert reviewers. We have also received further comments from a number of specialists. We hope that you will agree that the current versions are improved in terms of capturing the right information and in ease of use.
• These CRFs will be kept under regular review, and may be modified and updated by ISARIC collaborators as further clinical evidence emerges.

Under Development:

• Corresponding data dictionaries are currently in development and will be posted here as soon as they are finalized.
• Spanish, Portuguese and French translations

28 January 2016 | Version 1.0

Disclaimer: These CRFs are intended for use as a standardised document for the collection of clinical data in studies investigating the Zika virus. Responsibility for use of these CRFs rests with the study investigators. ISARIC and the authors of the CRF accept no responsibility for the use of the CRF in an amended format nor for the use of the standardised CRF outside its intended purpose. Formatting issues are in the process of being resolved. Word documents are available in order to adapt and translate the CRFs, however, there may be issues between macs and PCs. The PDF format is also available, which should be well formatted on both types of machines.

How to use

These CRFs are to be used at admission and at discharge/going home. For any patients with acute symptoms and admitted to hospital for more than 24 hours, the Baseline and Outcome CRF and the Laboratory Results CRF can be copied and used for daily data recording.

Each investigator and site may choose the amount of data to collect based on available resources and the number of patients enrolled to date. Ideally, researchers should collect data from eligible patients (neonate and mothers) using all of the above CRF modules as appropriate.

For studies only collecting data post-delivery, we recommend collecting a minimum data set using the following CRFs:

• Maternal and Neonate Baseline and Outcome
• Maternal and Neonate Laboratory Results

Sites with very low resources or very high patient numbers may choose to collect data using the following CRFs only:

• Maternal and Neonate Baseline and Outcome

These CRFs can be used and modified as appropriate and needed, depending on the type of study and resources available.

Please note that a central, electronic database is currently being developed by MedSciNet under the Zika Alliance Consortium.xt

For more information regarding any of the research tools posted on this page, please contact ISARIC's Clinical Coordinator Dr Gail Carson by email.

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