Please use this template as the basis for designing the Case Report Forms for your CTIMP Using your protocol, please add or delete pages on this template as required and ensure that data required in the protocol from all trial visits and data relating to endpoints defined in the protocol are captured in this CRF. It is also important that you ensure that you do not collect any data which is not required in your protocol, for instance if you are not required to collect alcohol and smoking history at screening you should delete this page in the template.
The following pages should be included in every CRF:
CRF Completion Instructions
Demographics (including informed consent details, but the ethnicity is not compulsory – if you do record ethnicity these are the categories provided in the 2001 Census and should be used)
Inclusion and Exclusion Criteria
Eligibility Review and sign off
Trial Medication Administration (choose the appropriate method of administration, or add your own)
Adverse events page
Concomitant Medications table
Principal Investigator’s sign off
As well as the compulsory forms, this template includes a number of elective forms (for instance laboratory results); these are by no means exhaustive and cannot cover every possible investigation, you should design these study specific forms yourself.
If you will be repeating investigations if they are out of range (for instance blood pressure or bloods), please add pages for these, clearly marking them ‘repeats’.
We have used ‘Subject No.’ throughout this template, if you have used different terminology (e.g. Screening No., Patient No., Enrolment No. etc.) in your protocol you should amend this template to maintain consistency.
Text given in blue should be completed before printing the CRF. Text given in green are for options or ‘as required’ details – please use or delete as appropriate. Please change the colour of all the text to black and white before printing.
Please note that the template has been broken in to sections so that different information can be added to the headers and footers as appropriate; note you may need to enter the information in to the header or footer of each section so that it appears on every page.
Section 1: Cover page and instructions
Section 2: Screening (Screening No. can be added to the header in this section if required instead of Subject No.)
Section 3: Post randomisation/enrolment visits
Section 4: AEs/ConMeds pages (landscape)
Section 5: PI sign off (portrait again)
This instruction page should be deleted once you have designed your CRF.