What You Need to Know about Case Report Form Design

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What You Need to Know about Case Report Form Design

A case‌ ‌report‌ ‌form‌ ‌is‌ ‌a‌ ‌special‌ ‌document‌ ‌necessary‌ ‌for‌ ‌every‌ ‌serious‌ ‌study.‌ ‌It‌ ‌has‌ ‌a‌ ‌determined‌ ‌structure‌ ‌and‌ ‌should‌ ‌be‌ ‌made‌ ‌in‌ ‌compliance‌ ‌with‌ ‌legislation‌ ‌and‌ ‌rules‌ ‌of‌ ‌the scientific‌ ‌community.‌ ‌There‌ ‌are‌ ‌special‌ ‌services‌ ‌where‌ ‌you‌ ‌can‌ ‌‌do‌ ‌CRF‌ ‌designs‌‌ ‌with‌ ‌the‌ ‌help‌ ‌of‌ ‌a pre-programmed‌ ‌platform,‌ ‌but‌ ‌you‌ ‌still‌ ‌need‌ ‌to‌ ‌know‌ ‌some‌ ‌basic‌ ‌requirements‌ ‌to‌ ‌avoid‌ ‌common‌ ‌mistakes.‌ ‌

The Nature of CRF

In‌ ‌simple‌ ‌words,‌ ‌it‌ ‌is‌ ‌a‌ ‌paper‌ ‌or‌ ‌electronic‌ ‌catalog‌ ‌of‌ ‌patient‌ ‌data.‌ ‌It‌ ‌has‌ ‌a‌ ‌major‌ ‌effect‌ ‌on‌ ‌the‌ ‌study’s‌ ‌success‌ ‌and‌ ‌is‌ ‌an‌ ‌obligatory‌ ‌requirement‌ ‌of‌ ‌sponsors.‌ ‌

The‌ ‌CRF‌ ‌contains‌ ‌all‌ ‌the‌ ‌data‌ ‌obtained‌ ‌from‌ ‌protocols,‌ ‌so‌ ‌it‌ ‌has‌ ‌to‌ ‌be‌ ‌designed‌ ‌perfectly.‌ ‌Even‌ ‌the‌ ‌slightest‌ ‌mistake‌ ‌can‌ ‌lead‌ ‌to‌ ‌research‌ ‌failure.‌ ‌Ideally,‌ ‌the‌ ‌scientist‌ ‌should‌ ‌be‌ ‌able‌ ‌to‌ ‌prove‌ ‌or‌ ‌reject‌ ‌a‌ ‌hypothesis‌ ‌just‌ ‌by‌ ‌analyzing‌ ‌the‌ ‌form.‌ ‌ ‌

To‌ ‌ensure‌ ‌the‌ ‌best‌ ‌result,‌ ‌input‌ ‌the‌ ‌report’s essential‌ ‌data‌ ‌into‌ ‌the‌ ‌form‌ ‌right‌ ‌after‌ ‌its‌ ‌finalization.‌ ‌‌ ‌CRF‌ ‌is‌ ‌recognized‌ ‌as‌ ‌a necessary‌ ‌condition‌ ‌of‌ ‌research‌ ‌quality in the scientific world.‌ ‌It‌ ‌guarantees‌ ‌the‌ ‌conformity‌ ‌of‌ ‌data‌ ‌and‌ ‌structures‌ ‌the‌ ‌results‌ ‌in‌ ‌the‌ ‌most‌ ‌acceptable‌ ‌way.‌ ‌

Presentation of the Data 

  1. The data presented in the form should not allow patient identification. Codes, numbers, or initials can refer to all the participants. It ensures data analysis without the risk of patients’ data disclosure.
  2. Keep track of versions if you fill in the form before at the same time as a report. It means that all the information and addition should be dated properly. Any discrepancies with the protocol are intolerable, so double-check the information. 
  3. You should register all the procedures and patient visits defined by a protocol in the form. The same is true for all self-observation diaries and questionnaires. 
  4. References to the corresponding protocols should accompany the lab measurements and other controllable data. Give a detailed explanation of all calculated and processed results.
  5. Avoid including the “other” option in the questionnaires, or at least leave a space for additional details from the participant.                                                                                                          There are many more requirements to the information included in CRF, but these points are the main ones to consider.

The Requirements to the Form Layout

Pay attention to the header and footer design. Include all the information about the place and facility conducting research, dates, and other study information. Keep in mind the requirements for formatting a final document. They include the recommended margins, font size, type, and text alignment. 

Don’t forget to put a number on each page in a visible position to eliminate the risk of misplacement. Leave a space on each page for the marks of a person making the final examination and assessment. Sign and date the form properly; otherwise, it isn’t verified, and the data is unconfirmed.

Include all mandatory forms and fields into the form and fill them, considering the requirements of the scientific institution you are planning to present the results to.

As you can see, the enormous complexity of the CRF makes it hard to take care of all the necessary aspects manually.

We recommend using automated design tools; they will do all the difficult work, leaving you time and resources to the study itself.

A case‌ ‌report‌ ‌form‌ ‌is‌ ‌a‌ ‌special‌ ‌document‌ ‌necessary‌ ‌for‌ ‌every‌ ‌serious‌ ‌study.‌ ‌It‌ ‌has‌ ‌a‌ ‌determined‌ ‌structure‌ ‌and‌ ‌should‌ ‌be‌ ‌made‌ ‌in‌ ‌compliance‌ ‌with‌ ‌legislation‌ ‌and‌ ‌rules‌ ‌of‌ ‌the scientific‌ ‌community.‌ ‌There‌ ‌are‌ ‌special‌ ‌services‌ ‌where‌ ‌you‌ ‌can‌ ‌‌do‌ ‌CRF‌ ‌designs‌‌ ‌with‌ ‌the‌ ‌help‌ ‌of‌ ‌a pre-programmed‌ ‌platform,‌ ‌but‌ ‌you‌ ‌still‌ ‌need‌ ‌to‌ ‌know‌ ‌some‌ ‌basic‌ ‌requirements‌ ‌to‌ ‌avoid‌ ‌common‌ ‌mistakes.‌ ‌

The Nature of CRF

In‌ ‌simple‌ ‌words,‌ ‌it‌ ‌is‌ ‌a‌ ‌paper‌ ‌or‌ ‌electronic‌ ‌catalog‌ ‌of‌ ‌patient‌ ‌data.‌ ‌It‌ ‌has‌ ‌a‌ ‌major‌ ‌effect‌ ‌on‌ ‌the‌ ‌study’s‌ ‌success‌ ‌and‌ ‌is‌ ‌an‌ ‌obligatory‌ ‌requirement‌ ‌of‌ ‌sponsors.‌ ‌

The‌ ‌CRF‌ ‌contains‌ ‌all‌ ‌the‌ ‌data‌ ‌obtained‌ ‌from‌ ‌protocols,‌ ‌so‌ ‌it‌ ‌has‌ ‌to‌ ‌be‌ ‌designed‌ ‌perfectly.‌ ‌Even‌ ‌the‌ ‌slightest‌ ‌mistake‌ ‌can‌ ‌lead‌ ‌to‌ ‌research‌ ‌failure.‌ ‌Ideally,‌ ‌the‌ ‌scientist‌ ‌should‌ ‌be‌ ‌able‌ ‌to‌ ‌prove‌ ‌or‌ ‌reject‌ ‌a‌ ‌hypothesis‌ ‌just‌ ‌by‌ ‌analyzing‌ ‌the‌ ‌form.‌ ‌ ‌

To‌ ‌ensure‌ ‌the‌ ‌best‌ ‌result,‌ ‌input‌ ‌the‌ ‌report’s essential‌ ‌data‌ ‌into‌ ‌the‌ ‌form‌ ‌right‌ ‌after‌ ‌its‌ ‌finalization.‌ ‌‌ ‌CRF‌ ‌is‌ ‌recognized‌ ‌as‌ ‌a necessary‌ ‌condition‌ ‌of‌ ‌research‌ ‌quality in the scientific world.‌ ‌It‌ ‌guarantees‌ ‌the‌ ‌conformity‌ ‌of‌ ‌data‌ ‌and‌ ‌structures‌ ‌the‌ ‌results‌ ‌in‌ ‌the‌ ‌most‌ ‌acceptable‌ ‌way.‌ ‌

Presentation of the Data 

  1. The data presented in the form should not allow patient identification. Codes, numbers, or initials can refer to all the participants. It ensures data analysis without the risk of patients’ data disclosure.
  2. Keep track of versions if you fill in the form before at the same time as a report. It means that all the information and addition should be dated properly. Any discrepancies with the protocol are intolerable, so double-check the information. 
  3. You should register all the procedures and patient visits defined by a protocol in the form. The same is true for all self-observation diaries and questionnaires. 
  4. References to the corresponding protocols should accompany the lab measurements and other controllable data. Give a detailed explanation of all calculated and processed results.
  5. Avoid including the “other” option in the questionnaires, or at least leave a space for additional details from the participant.                                                                                                          There are many more requirements to the information included in CRF, but these points are the main ones to consider.

The Requirements to the Form Layout

Pay attention to the header and footer design. Include all the information about the place and facility conducting research, dates, and other study information. Keep in mind the requirements for formatting a final document. They include the recommended margins, font size, type, and text alignment. 

Don’t forget to put a number on each page in a visible position to eliminate the risk of misplacement. Leave a space on each page for the marks of a person making the final examination and assessment. Sign and date the form properly; otherwise, it isn’t verified, and the data is unconfirmed.

Include all mandatory forms and fields into the form and fill them, considering the requirements of the scientific institution you are planning to present the results to.

As you can see, the enormous complexity of the CRF makes it hard to take care of all the necessary aspects manually.

We recommend using automated design tools; they will do all the difficult work, leaving you time and resources to the study itself.

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