Hello, Teerawat. I appreciate that I have been assigned to review your CRF. Your CRF appears to be very impressive. 😊 Please find my following comments:
– I would suggest relocating the ‘Informed consent process’ to the first section of the CRF, preceding the ‘Demographics’ section. This is because the ICF process should be carried out as the initial step in every procedure.
– Regarding the eligibility criteria section on Page 3, I recommend either removing the “N/A” (Not applicable) option for Inclusion criteria No. 1-3, or replacing it with “Not done.” The “N/A” option should only be kept for Inclusion No. 4, in the case of male participants. To implement exclusion no. 2, kindly include a ‘N/A’ option for male participants.
– In the Laboratory Test (Female Only) section, I suggested replacing the ‘Serum pregnancy test’ with the ‘urine pregnancy test’ based on the study synopsis.
– The CRF page for ‘subject disposition visit’ is not available. If the subject is not eligible for the study, I would suggest including a specific box for the reason for ineligibility can be entered, such as full enrollment or meeting exclusion criteria.
– In regards to the Informed Consent Process (Page 4): Kindly include a box in which the time of the Informed Consent Form (ICF) is provided.
– Vital signs section (Page 5): The study description does not include precise information about the route of temperature measurement for the ‘Temperature’ variable. I recommend changing ‘Oral Temperature’ to ‘Body temperature’ and including the subsection ‘Route of temperature measurement’ below ‘Body temperature’. The options for selecting should be ‘Oral’, ‘Forehead’, ‘Axillary’, or ‘Other’ with the box to specify. Next, the ‘Not done’ checkbox should be added for each Vital Sign.
– PE (Page 6): I recommend including the ‘Time of assessment for PE’. The Vital signs and Physical Examination (PE) are recorded on a separate Case Report Form (CRF) page. Therefore, it may be ensured that the physical education (PE) time is conducted after the ICF is signed. I would like to include an additional category called ‘Other categories’ below the ‘Metabolic/Endocrine’ row to record additional PE systems.
– I would suggest modifying the section titled ‘Eligibility check’ to ‘Subject history’ or ‘Medical history’ instead.
– Subject Check (Page 7): As per the sentence ‘If this is answered NO, please clarify’ in this section, I suggest adding a specific box for the reason for ineligibility that can be entered.
– Laboratory Test (Page 8): The study synopsis states ‘Immunogenicity will be evaluated using the hemagglutination inhibition (HAI) assay to measure influenza antibody level (reported as HAI titer)’. I would suggest removing the part on ‘Safety Labs – Blood Sample Collection’ from this page.
– Specialty Labs – Blood Sample Collection (Page 7): Please add a text box for entering the ‘HAI titer’ for each category of HAI.
– Randomization Process (Page 9): I greatly appreciate this topic you have created since it is an excellent tool for generating numbers related to the subject. Just to update the “Serum pregnancy test” to the “Urine pregnancy test” following the study synopsis.
That’s great!
Siriluk