1. DESIGN OF CRF
CRF

2. RDC/RDE (Remote Data Capture,
CRF
Official clinical data-recording document or tool used in a clinical study
RDC/RDE (Remote Data Capture,
Remote Data Entry)
PAPER

3. GUIDELINES FOR CRF DESIGN:
The measurement and recording of the trial data are perhaps the most critical steps in the overall data management process, and it is therefore important that the CRFs be designed with clarity and ease of use in mind.
The data collection forms should be concise and collect only the necessary data.
GUIDELINES FOR CRF DESIGN:
 Ensure that the data results of clinical trial are accurate.
 Ensure that the rights, integrity and confidentiality of trial subjects are protected.

4. PRINCIPLES FOR CRF DESIGNING
It should be
1. Clear
2. Concise
3. Consistent with the Protocol
IMPORTANCE
1. Ensures consistency across the patients.
2. CRF should be clear and easy to understand.
3. Aids more computerization.
4. Efficient for Clinical Data Management.
5. Flow of CRF should closely depends on data flow.

5. MINIMUM STANDARDS FOR DESIGNING THE CRF
Document the process of CRF design, development and approval.
Make sure that the designed CRF is available for the review prior to the patient enrollment.
Make sure that the reviewed CRF is available for clinical site prior to the patient enrollment.
 Document the training of clinical site persons on CRF Completion Guidelines (CCG).

6. IMPORTANCE:
Ensures consistency across the patients.
2. CRF should be clear and easy to understand.
3. Aids more computerization.
4. Efficient for Clinical Data Management.
5. Flow of CRF should closely depends on data flow

7. THE KEY POINTS DURING CRF DESIGNING:
 Avoid duplicate data entering.
 Avoid unambiguous data entry.
Ex: patient is not taking drug . Y \ N (wrong method)
 
Is patient taking drug? Y \ N (correct method)
 
Avoid long-term discussions.
 Provide adequate space.
 Provide clear instructions.
Format should be concise.

8. CRF Design:
Protocol  Create CRF  Produce CRF  Distribute CRF  Complete CRF  Retrieve CRF.
Possible Format of Questions:
Multiple Choice Formats:
For a specific question, all possible answers are displayed on the form, and the user has to circle/check the correct answer
This format is usually used if optical scanning is going to be used to convert the answers into electronic format.

9. CRF DESIGN Protocol Create CRF Produce CRF Distribute CRF Complete CRF
Retrieve CRF.

10. 2. Self - Coding Forms — Numeric Codes.
All possible answers to a question are displayed on the form, and each answer is assigned a numeric code.
There is a space or box (es) on the form to enter the code corresponding to the correct answer.
3. Self - Coding Forms — Non - numeric Codes.
All possible answers to a question are displayed on the form, and each answer is assigned a code that is more meaningful than a randomly assigned numeric code. There is a space or box (es) where the answer is to be entered, and the user is required to enter the code corresponding to the correct answer.

11. Format of Questions.
Keep the text of the question as short as possible while still retaining the meaning. The question does not have to be posed as a complete sentence if a short phrase is sufficiently clear
Use terminology that will be familiar to the person completing the form.
Ask only one question at a time, and do not introduce compound questions that can be confusing .
Instructions should be positive rather than negative, telling the person completing the
form what to do rather than what not to do.

12. LAYOUT OF CASE REPORT FORMS:
Format 1
The responses aligned on the Right - hand margin, and data entry can be done by reading the actual questions.

13. Format 2
The responses aligned on the left - hand margin, and data entry can be done by reading the actual questions.

14. Format 3
The responses aligned on the Right - hand margin, and data entry can be done by reading the actual questions.

15. Format 4
The responses aligned on the Right justified margin, and data entry can be done by reading the actual questions.

16. Types Of Responses Open—including text, number, alpha numeric.
2. Closed—including binary and multiple choice.
3. Combination—of the open and closed response.
Open
‘The actual answer cannot be predicted so an allocated area is provided for the written response.
Space The main concern is to allow sufficient space for the answer. Handwriting is unique to the individual but measurements/numbers/alphanumerical identifiers of known magnitude can be allocated at least 0.5 cm width per character.

17. Dates. Various indigenous formats exist, that is:
dd/mm/yy in most of Europe and parts of Canada
mm/dd/yy in the USA and parts of Canada
yy/mm/dd in Scandinavia
Time.
In CRFs, Clock Time is standard collected using the 24-hour clock or military time, instead of the domestic format of a.m. or p.m. With reference to the 24-hour clock, two formats exist depending on the culture and the Sponsor’s database; they are:
1. 00:01—24:00 (midnight).
2. 00:00 (midnight)—23:59.

18. Signatures.
Signatures are a special form of the open text response and although signatures can be influenced, a personal survey suggests that 90% of signatures will be accommodated by a minimum space of 3.0 cm × 6.0 cm.
Closed
‘The content of the answer is predicted, and a list of options can be provided, but the range is limited.’ The advantages to the Form Filler are that the list of answers clarifies the meaning of the question and it is simple to make a choice. The selection method is important.

19. Combination
‘Extends the range of the closed format by the addition of an open format.’ Other, specify. As the last item in a multiple choice list the open text response of ‘Other, specify’ introduces a disruptive element in the middle of a numerical database providing tables for analysis.