Topic Discussion 3 : CRF design

[Saranath]

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

[Kansiri Apinantanakul]

My suggestion would be in terms of collecting of “Date” data (date of visit, date of birth, data of informed consent signed). I think it should be in pre-printed box format like in the pulse rate or body temperature box. The data format should be in DD/MMM/YYYY in order to prevent confusion in data entry.

[TARO KITA]

As explained in the lecture, items that can be calculated from the data collected at the same time, such as BMI, should not be included to avoid inconsistencies due to calculation errors.

[Saranath]

Good catch! Waiting for others to participate.

[Yanin Pittayasathornthun]

Should we provide choices of race?

[Andrew Hall]

We should along with the choices for race include a “specify other” option, right?

[Karina Dian Lestari]

My suggestion is to delete the “Date of birth” field to avoid collecting participants’ privacy data.

[Ashaya.i]

In “pregnancy test”, we should provide the choice “Not Applicable” or “not done” in case of the subject is male or in any other conditions, to prevent leaving the question blank in the CRF and ensure validity of the data.

[Napisa Freya Sawamiphak]

Good point!!!. I found several questionnaires and other data collection forms providing choices only yes/no, negative/positive without “not applicable: option. The good point is it is mandatory for users to choose either choice but the disadvantage is like you mention. For someone who actually don’t know about that or no data, the section is likely to leave blank.

[Arwin Jerome Manalo Onda]

I also observed this, since not all participants will be female. There should be a “Not applicable” option. Great spot!

[Andrew Hall]

I would suggest adding a check box in the temperature question with the letter “F” for Fahrenheit, as per the CDISC. The user could then choose “C” or “F” for the unit. If one of the study sites in the US, body temperature analysis likely will default to Fahrenheit.

[Hoang Thuy Linh]

the unit of weight, height
abnormal (physical exam): should not open answers
date (birth, visit…) : format dd/mm/yyyy
age: redundancy information

[Napisa Freya Sawamiphak]

For weight and height, we can use box format with clear unit to prevent data entry error and easy to understand. However, the recent format is still acceptable (if added written units)

[Saranath]

Good catch all! There are more points that are needed to be improved. Perhaps, you all can help adding those points, as it is over the deadline. I will provide the complete answer(Revised CRF) in week 5 module.

[Arwin Jerome Manalo Onda]

Some fields have units (eg, pulse rate, temperature), while some don’t have (eg, blood pressure, weight). My colleagues have covered most of my observations as well.

Perhaps, in Physical Examination, it’s too open ended if an investigator tries to specify the abnormality. Perhaps, choices based on the organ system would be a great start in classifying abnormalities observed during physical examination.

[Sri Budi Fajariyan]

The date of birth does not need to be asked, it is enough to ask for age, because the date of birth includes identifiable data

[Tossapol Prapassaro]

A pregnancy test is a lab result, and should not be the part of a physical examination.

[Pawdoo Paoprapat]

These variables should be indicated as well, with the answer in yes/no checkbox line by line.
– Receipt of any vaccine during the 4 weeks
preceding the trial
– Plan to receipt of any vaccine during the 3 weeks
following the trial
– Vaccination against influenza in the past 6 months
– Self‐reported history of influenza infection in the
past 6 months

[Pawdoo Paoprapat]

Time of ICF signed should also be provided, with the instruction filling out in dd/mmm/yyyy format.

[Pawdoo Paoprapat]

Date of Birth should be replaced with “Year of Birth”.

[Anawat ratchatorn]

– Height and weight – should provided Unit such as CM, Kg.
– Pregnancy test – should be in Lab section and should have “not done” choice
– variable number should be align between Physical Exam and Pregnancy Test. If for Physical Exam 0 = Normal, 1 = Abnormal it should be applied for pregnancy test. We should change it from Negative =1, Positive =2 to Negative = 0, Positive =1, and Not done =3.

[Author]

Posts