Hi Soe, thank you for sharing your CRF completion. You did quite well, but I would like to suggest adding more ideas that could be helpful as references for creating a CRF.
FYI – this is better if Demographics should be separated from Eligibility section in CRF creation, it might be easier to collect and enter data and reduce error upon completion.
Furthermore, please allow me review and provide more information of improvments of your CRF creation due to the classmate who I have been assigned to review, they have not submitted the CRF completion yet.
Demographics:
• Each CRF should have a standardized date format e.g. DD/MMM/YYYY to be collected for any assessments
• Recommend to use the format of subject ID: site(2 sites for this study) – subject number (150 subjects in each site) e.g. 01-001, 02-001, 01-002, 02-002… until 01-150, 02-150
• May require to collect the year birth for recording
• Should have options for gender and ethnicity
Eligibility Criteria:
• Should create all options for Inclusion Criteria (4 choices of criteria) and Exclusion Criteria (7 choices of criteria), this will ensure that each subject will be proceeded further
• Should collect Date/Time of Sample Collection for performing Pregnancy Test
• Informed Consent form should be signed and handled to each subject and collect date/time of Informed Consent obtained
Vital Signs:
• Should create this part separately to include as below examples
Date of Vital Signs: __ __ / __ __ __ / __ __ __ __ DD/MMM/YYYY
Time: _ _: _ _ hh:mm (24 hr)
Height: _ _ _ cm
Weight: _ _. _ kg
BMI: _ _. _ _ kg/m2
Body Temperature: _ _. _ Celsius
Systolic Blood Pressure (SBP): _ _ _ mmHg
Diastolic Blood Pressure (DBP): _ _ mmHg
Pulse Rate: _ _ beats/min
Respiratory Rate: _ _ breaths/min
Pulse Oximetry (SpO2): _ _ _ %
Physical Examination:
• Should indicate related categories e.g. General Appearance, HEENT, Respiratory, Cardiovascular, Dermatological, Musculoskeletal, Neurological and others, these should be provided choices to opt for test results such as Normal, Abnormal, not clinically significant, Abnormal, clinically significant and Not Done
Subject Check: each subject should be asked to re-check their eligibility and other parts for testing before proceeding with Laboratory Test e.g. Is the subject eligible to participate in the study? Yes or No
Laboratory Test:
• Should create below categories to perform tests
– Hematology
– Serology
– Chemistry
– A/H1N1 AntibodyTiter
– A/H3N2 AntibodyTiter
– B/Yamagata‐lineageAntibodyTiter
– B/Victoria‐lineageAntibodyTiter
Randomization Process:
• Should create Randomization Group to specify vaccine type, but this should be blinded with subject as this is a single blinded, randomized trial
• Should add Local Date/Time of Randomization (GMT+7) with standardized format of units
• Could Add Randomization ID
Study Vaccine Administration:
• Should add Date/Time of Study Vaccine Administration
• Add Injection Location e.g. Right Deltoid or Left Deltoid
Post-Dose Vital Signs:
• Should create post-vital signs after finished vaccination e.g. to observe and collect Vital Signs + 60 mins Reactogenicity Assessment (Solicited Reactions) + Subject Checks + provide eDiary login credentails and instructions to record Diary entries
Additional forms may be created that concerns to data collection, they may be performed after finished Physical Examination as Eligibility Check if applicable:
• Medical History Form
• Adverse Events Form
• Prior and Concomitant Medications Form
I can see how hard you’re working on the CRF and I want to encourage you to keep going! Let’s keep the momentum going together! 😊