1. Case reports and sites activities
Investigator Meeting 2018
Case reports and sites activities
Biljana Brezina
9 March 2018, Cambridge

2. Case reports forms (CRF’S)
Tips (top 3)
Brief review of the documentation/samples/questionnaires requirements prior to the visit (10 to 15 minutes)
Complete the CRF’s as much as possible during the visit or just after
Communications (keep everyone that might be involved informed, and remind them regularly)

3. Visit Schedule † Procedure Screening Wk -2 Baseline Wk 0 Wk 4 16 32
Consent ✓
Disease assessment - Harvey Bradshaw Index (HBI)
Concomitant medication
Weight in Kg
Physical examination
Eligibility confirmed
Randomisation
PAXgene RNA tube for biomarker assessment
PAXgene RNA tube for research sample
Serum tube
EDTA tube
Bloods (FBC, CRP, U&E, Creatinine, LFT) ✓†
Bloods (Hepatitis B & C, VZV, TPMT and Tuberculosis testing)
Bloods (6-TGN and 6-MMP = thiopurine metabolites) ✓α
Stool sample for faecal Calprotectin †
Buffered stool sample
Patient rated Questionnaires
Colonoscopy ✓*
Magnetic Resonance enterography or enteroclysis (MRE) ✓¥
Adverse event reporting

4. CRF’s completion guidelines
The current & correct version of the CRF form must be completed
Use ticks
All dates are to be completed in the sequence day/month/year (DD/MMM/YYYY) with the month written using LETTERS not numbers
Enter a digit in each box provided, if three boxes are provided but only two are required please enter a preceding 0
Where data are not available please do not leave the answer blank as this will create unnecessary data queries
Please include one of the following abbreviations instead:
NK = Not known
NA = Not applicable
ND = Not done
Errors should be crossed out with a single line (i.e. mistake), the correction inserted and the change initialled and dated by the investigator or designee

5. Screening CRF’s Patient data to collect Gender Date of birth HBI
Height & Weight
Medical history/physical examination
Results of colonoscopy performed within 3 months of the baseline screening assessment visit (including video-recording of procedure where possible)
Results and images of MRE if performed within 3 months of screening visit (pre or post)
IBDQ & EQ-5D, patient rated quality of life measures

6. Screening samples-locally
Results of hepatitis B & C and Varicella Zoster Virus blood test within 1 year of the baseline assessment
Results of tuberculosis (TB) testing (TB testing can be either performed as a chest x ray or blood test, as per local preference) within 1 year of baseline assessment
Pregnancy test for female participants
Full blood count
Biochemical series (including urea, creatinine, electrolytes, liver function tests, TPMT, CRP)

7. Screening samples-centrally
PAXgene RNA tube x2 (biomarker assessment & research sample), Serum tube and EDTA tube
Stool sample for faecal Calprotectin
Buffered stool sample

8. Baseline CRF’s Patient data to collect HBI
Significant past medical history
Concomitant medications
Adverse events
Weight in kilograms
Physical examination
IBDQ & EQ-5D, patient rated quality of life measures and resource use patient questionnaire

9. Baseline samples-locally
Full blood count
Biochemical series (including urea, creatinine, electrolytes, liver function tests, and CRP)

10. Week 4 CRF’s Patient data to collect HBI Treatment compliance check
Concomitant medications
Adverse events
Weight in kilograms
Physical examination

11. Week 4 samples-locally Full blood count
Biochemical series (including urea, creatinine, electrolytes, liver function tests, CRP), [6-TGN and 6-MMP if taking Azathioprine or 6-Mercaptopurine]

12. Week 16 & 32 CRF’s Patient data to collect HBI
Treatment compliance check
Concomitant medications
Adverse events
Weight in Kilograms
Physical examination
IBDQ & EQ-5D, patient rated quality of life measures and resource use patient questionnaire

13. Week 16 & 32 samples-locally
Full blood count
Biochemical series (including urea, creatinine, electrolytes, liver function tests, CRP), 6-TGN and 6-MMP if taking Azathioprine or 6-Mercaptopurine

14. Week 16 & 32-centrally PAXgene tube Serum tube
Stool sample for faecal Calprotectin

15. Week 16 important
Baseline MRE data will be collected at the week 16 CRFs

16. Week 48 CRF’s (end of study visit)
Patient data to collect:
HBI
Treatment compliance check
Concomitant medications
Adverse events
Weight in kilograms
Physical examination
IBDQ & EQ-5D, patient rated quality of life measures and resource use patient questionnaire
Colonoscopy results & images (can be performed up to 4 weeks after week 48)
MRE (can be performed up to 6 weeks after week 48)

17. Week 48 samples-locally Full blood count
Biochemical series (including urea, creatinine, electrolytes, liver function tests), CRP), [6-TGN and 6-MMP if taking Azathioprine or 6-Mercaptopurine]

18. Week 48 samples-centrally
PAXgene tube
Serum tube and EDTA tube
Buffered stool sample
Stool sample for faecal Calprotectin

19. CRF’S management
Source data will be the patients medical records/trial notes kept at site
Screening CRF’s ASAP, within 7 days
Other CRFs within 14 days
scanned copies
Original copies to site file

20. Things to consider when filling in the CRF’S (part 1)
Source data findings
Paper source without initials and date – NOT ATTRIBUTABLE
INACCURATE source data
“ Pt XXX consented to (trial name) - 3/02/15”  
“ To start (trial name) treatment - 9/01/15”
INCOMPLETE: Inadequate or unclear documentation of patient visits and assessments.
Eg. Eligibility review and outcome unclear
Eg. No Trial Visit number / no documentation of AEs or Conmeds

21. Things to consider when filling in the CRF’S (part 2)
The protocol signature date could not be confirmed -- signed in ink by the Chief Investigator but the date was pre-printed and could not be verified as the date of signature.
Documents filed are: incorrect / duplicated / inconsistently filed / in the wrong sections
Documents not filed in a timely manner
About File notes
File notes missing
File notes used inappropriately -- File Notes should be used to provide clarification or signpost to other documents or provide an explanation about something in the trial; File notes should not be used to document protocol related issues.
About s:
s filed with no structure or repeated via chains
Key s not filed
Incomplete chain of s hence unable to explain the issue or topic in full

22. Thank you

23. Any questions?