Topic Discussion 3 : CRF design

[Saranath]

 

Please help to improve this CRF. One spot per each student.

 

[Zarni Lynn Kyaw]

I believe using
consistent formats for the dates (DD/MM/YYYY) is a good idea, as well as using
consistent units for the measurements (like making weight and hight to KG and Meter, so BMI could be easily calculated),
Age could be two [] [] boxes as the study is only between 18 to 60,
race could also be a multiple choice as well, and
replacing “given” with “administered” in the title to “Immunogenicity and Safety of a Quadrivalent Influenza Vaccine Administered Intramuscularly in Participants Aged 18 to 60 Years” would make it more professional

[Wichayapat Thongrattana]

I also think the unit measurement is important but the unit should also relied on the preference of the individual. Since the conversion those are performed in later analysis process.

[Tanyawat Saisongcroh]

Note that if this study conduct in Thailand, people may familiar with year in B.E. (Buddhist Era), however, some participants might be foreigners, so, I think for the year should be in A.D.

[Boonyarat Kanjanapongporn]

Comment above did mentioned many good points to improve this CRF. I would suggest amending the open ended question at Physical examination on Abnormal specifying. The blank spaces provided might not be enough for people who have many conditions and the hand writing might be hard to read if the condition is complicated.
Therefore, I suggest the checkboxes differentiate physical body parts such as HEENT, Cardiovascular and Abdomen.
Moreover, if there are other variables that need adding in the screening form, the checkboxes, for eligibility of the enrollment, could be added to conclude the screening results before entering to vaccination record.

[Jintana Pankam]

Please help to improve this CRF. One spot per each student.

Due to there were many points were mentioned, I will suggest other things. In my opinion about the heading “screening and vaccination”, The CRF have to consist of more details such as medical history or the data for receiving vaccine.

[Wichayapat Thongrattana]

In my opinion, the place holder format of blood pressure should be in the box format as the other variable in the same field. This should be fix to avoid the doubt of speciality that field among the other in filling the information. Even this point is kind of small, the improvement of this could potentially reduce the confusion and time to complete the CRF.

[Boonyarat Kanjanapongporn]

I agree that keeping consistent format throughout the CRF, would reduce the time consumption when filling the form.

[PREUT ASSAWAWORRARIT]

The pulse rate should have 3 digits.

[Tanatorn Tilkanont]

To avoid the thing that could be calculated such as BMI, we may not need users to calculate BMI by themselves and record data in CRF. However, BMI can be auto-calculated by using value of weight and height. Moreover, there must be a unit and space with decimal number provided for weight and height as well, to ensure the same standard format.

[Tanatorn Tilkanont]

Sorry, I just notice the BMI point was already mentioned.

Please allow me to share another point.
I think for Pregnancy Test, there must be another checkbox for “Not Done”, in case of male subject or the test was not done in some other reasons such as infertile female or female sterilization.

[Tanyawat Saisongcroh]

Date of Birth variable;
Date of birth here might be unnecessary and it is also one of the indirect identifiable data. We could check the participants’ ages in the screening visit whether they are in 18 to 60 years old or not. Also, we can just put “year of birth (yyyy)” instead of full date of birth.

[Hazem Abouelfetouh]

– If we have more than 9 sites, we should add a box to the site ID.
– We should identify units for weight and height
– To improve the response, we can add “Not Done” to the pregnancy test and other physical examinations.

[SIPPAPAS WANGSRI]

Date of informed consent and date of birth would be great if they are properly labelled as

______ / ______ / ______
(Date) (Month) (Year)

Without label, how would you know whether which format they intent to fill.
Take this for example

Date of birth: 05/04/1989
Is it 5th April 1989 or 4th May 1989 ??
Not all people write date in DD/MM/YYYY format, right? Some may prefer MM/DD/YYYY. we don’t know.
So it’s best to predefine the format and explicitly write down to guide whoever fills this form.

[Siriphak Pongthai]

Pregnancy test should have available choice for subjects who are male. In order to avoid blank space, the CRF should provide N/A option.

[Myat Thiri]

I think it will be better knowing ID of the person who check the physical examination or who enter the data. If something is unclear, we can ask that person.

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