Please note that the following comments are simply my suggestions for improvement of the CRF and are not intended as judgments. I hope this might be helpful for your CRF.
Specific Comments
1. Instructions: The CRF lacks clear instructions. When administering the CRF, we need to specify whether participants will complete it independently or with an interviewer.
a. If participants complete it independently, the CRF should explain the objective and how to fill it out.
b. It should also clarify how participants should mark their answers (e.g., check a box) and how to correct any mistakes.
2. Paper-Based CRF: Since this is a paper-based CRF, we should consider potential consequences of losing a page. We might want to:
a. Implement strategies to prevent page loss.
b. Include a Case ID on each page to allow for reassembly if pages become separated.
3. Case ID and Screen ID: Using numbered boxes for entering Case ID and Screen ID would be helpful as it clarifies the expected number of digits for participants. This can minimize errors in data entry.
a. Additionally, some participants might use hyphens (e.g., 123-45) when entering IDs. Numbered boxes would discourage this practice and ensure consistency in data format.
b. It’s also important to address how leading zeros should be handled (e.g., 012345 vs. 12345). Numbered boxes would encourage participants to include leading zeros where necessary.
4. Age: Similar to IDs, using a numbered box for age would minimize recording errors.
5. Gender: While gender is traditionally categorized as male or female, it’s important to acknowledge the growing recognition of gender identities beyond this binary. However, if the CRF requires a two-category response, consider using a more inclusive term like “Sex assigned at birth” in the label.
6. Checkbox Values: The CRF should assign specific values to each checkbox option. For example, “Male” could be assigned a value of “1” and “Female” a value of “2”. This clarifies data entry for coders.
7. Date Format: To prevent errors, the CRF should specify the required date format. For example, the format could be YYYY-MM-DD (year-month-day). Additionally, consider specifying whether participants should enter dates according to the Anno Domini (AD) or Buddhist Era (BE) calendar system.
8. Decimal Notation: The CRF should clarify whether participants should include decimals when recording weight and height (e.g., 175.5 cm vs. 175 cm).
9. Laboratory Results: The CRF should specify the units of measurement required for laboratory results (e.g., mg/dL for blood sugar). This ensures consistency across all study sites.
I hope these suggestions are helpful. Thank you.