The King’s Health Partners Clinical Trials Office

Case Record Form Design Manual

Introduction

When drafting a Case Record Form (CRF), please refer to the applicable SOP and this design manual. The CRF template comprises mandatory pages, which must be used for all trials and a selection of elective pages; which can be added to the mandatory pages to accommodate trial requirements. The list of elective forms is by no means exhaustive and will continue to be added to. If you require a form that is not on the list please contact your KHP-CTO CRA for assistance. All new forms designed will be published.

Before creating a CRF using the KHP-CTO template:

  • Review the mandatory CRF pages to identify the information required. Page content is for example only and can be amended to reflect the protocol.
  • Consider data flow and study procedure for the trial
  • Identify elective CRF pages to be added to the mandatory CRF

To add an elective CRF page to the mandatory CRF:

  • Cut and paste the mandatory and elective CRFs into a Microsoft Word document
  • Ensure that pages are copied in their entirety.
  • Ensure that the page numbers are amended within the footer of the document.

Continuation pages:

There are certain CRF pages which are likely to require more than one page, for example, Adverse Events Log, Concomitant Medications Log.

General Instructions

  • Enter the correct protocol name / number in the top right hand box in the page header for each CRF page (see figure 1 below).
  • Site number / Screening Number / Participant Study Number may be amended to capture preferred information, e.g. Site number can be replaced by Participant’s Initials if preferred. IMPORTANT: Do not use information that can identify the participant
  • Ensure header information is always at the top of the page
  • Visit name should correspond with the protocol
  • “Date of Visit / Date of Assessment” must be included on all applicable pages as a data point that must be recorded.
  • < > includes instruction to enter specific text, these are to be replaced by the required text as specified.
  • Where a second CRF page is required for a specific type of assessment, the first page can be identified as (1), second page as (2) and so on.
  • Page footer must be amended to include short study title and version of the CRF.

Figure 1 Header information:

Site Number / Screening Number / Participant Study Number / Protocol Number
VISIT 1 (SCREENING) / demographic data

CRF Cover page:

  • Insert Protocol Name, Protocol Number, Name of Trial Sponsor as indicated.
  • Site numbers are recommended for multi-centre trials (each site has a unique identifying number). However, this may be deleted for a single-centre trial
  • Terminology of Screening Number and Participant Study Number should correspond with terminology used in the protocol. They can be amended to correspond with protocol if required.

Confirmation of Consent & Demographics

  • If additional demographic data is required by the protocol, please add to CRF page where applicable.

EligibilityCriteria:

  • Insert the exact same inclusion/exclusion criteria as in protocol.
  • Delete rows if not used.
  • NA can be shaded for criteria only to be answered as “Yes”.

Participant Eligibility Review:

  • Enter or remove questions from the “End of Screening Visit Checklist” according to protocol requirements.
  • If the trial is a randomised controlled trial, add in the instruction to “complete Randomisation Page” if the participant is eligible to enter the trial.

Administration of Trial Medication:

  • This is an example of a Trial Medication Administration page, please select appropriate Trial Medication Administration page from the elective pages that best suit the trial requirements.

Participant Status:

  • Enter or remove questions from the “Visit Checklist” according to protocol requirements.

Adverse Events Log (including continuation page):

  • This page should only be amended only if necessary per protocol.

Trial Completion:

  • The list of early withdrawal categories may be amended as per the trial protocol.

Principal Investigator’s Sign Off:

  • Changes should not be made to this page

It is advisable to include an Unscheduled Visits form within the CRF although this is not mandatory.

17/Jan/18 Final v2.0 Page 1 of 3