CRF Development From Protocol

 CRF Development From Protocol

✓ Contents to be covered:

✓ What is mean by CRF

✓ CRF & it types

✓ What are the Challenges occur while designing CRF?

✓ Considerations for designing a CRF

✓  Designing CRF in standard form

✓ CRF template(standard)

✓ eCRF & Importance of eCRF

✓  Conclusion

What is CRF

Case report form

It is defined as the collection of data from each subject which is required for study. It serves as a tool for sponsor to conduct clinical trials. It is developed by sponsor to collect specific data regarding subject.

The primary goal to design the CRF is to collect the protocol required data which should be analyzed according to protocol and statistical analysis.

reducing the queries and avoid errors is considered as secondary goal of designing CRF

The size of CRF may vary. It can be a onetime snapshot or number of pages.

It can be paper based or computerized (which is called as Ecrf)

CRF contains the data which accurately represents protocol of the study, which is audited and monitored.

The main objective for preparing CRF is to obtain accurate data with less or NO errors.

However, there is human intervention or machine errors. Ecrf’s are designed to overcome those errors, the system itself fires a query if there is any error in the data -auto query.

If there are any manual queries (not detected by system) to be raised by team -monitors, should be crosschecked while raising the query

Monitor- the one who performs audits and confirms that CRF contains perfect data. Monitors are hired by sponsor.

Types of CRF:

CRF is classified into

Standard CRF: it will be same for all protocols and study.

Study specific CRF: it varies with the study design so called study specific.

Challenges in designing the CRF:

As we know that, designing a CRF is a challenge. The following are the challenges encountered during the CRF design:

✓ Consistency

✓ Collection of precise data

✓ User friendliness

✓ Objectives of study should be clearly mentioned before designing CRF

✓ Avoiding collection of extraneous data

✓ Quality & accuracy of data should be maintained

✓ Avoid errors in data collected

• One can overcome these challenges by using CRF templates &can also be overcome by the team of members (data managers, biostaticians, clinicians, medical writers)

CRF design considerations:

The following are to be considered while designing CRF

✓ LOG forms for AE, CM & so on

✓ Questionaries

✓ Diagrams & analog scales

✓ Early termination pages

Standard CRF design

It should be designed in such a way by keeping the user in mind (user friendly)

The sections should be designed with care, avoid duplications, data should be sufficient &accurate /high quality data is required.

Primary efficacy & safety should be considered avoiding collection of unimportant data & collected data should be placed accordingly in a format.

Data entered in each page should be limited, more data in one page may create clutters & will be difficult to data manager to read hence, leads to data discrepancy.

Below are some points which should be considered while designing a CRF

✓ Consistent format, font style, size

✓ Selection of design (portrait /landscape)

✓ Clean & concise questions and prompts

✓ Check boxes would be appropriate instead circling of answers which are hard to interpret

✓ Clear instructions about skips and not skips (skip guidance provided in each CRF page to maintain connectivity)

✓ Provide separate boxes for sponsor and investigator to record their response for query raised

✓ Bold & italic instructions

✓ Page number, if needed

✓ Units of measurements should be specified

✓ Recorded number of decimal places should be indicated

✓Standard data format

✓ Precoded answer codes (yes/no) (male/ female) for AE (mild / moderate/ severe) should be used

✓ Spilt in modules or duplicate sections should not be used

✓ To ensure replication “no carbon required” option should be used

✓ Instructions such as where the data has to be entered should be mentioned (e.g., information regarding particular section should be placed in that particular module)

CRF design template

Template should be developed as the data will be same for AE, DM & so on across the study.

These templates help in conducting multiple studies for the same study drug or same site

These templates are maintained by sponsor/ CRO

The main purpose of developing templates is to maintain uniformity & it will be a time saving

These templates contain following data

Inclusion/exclusion criteria, Demographic form, medical history, AE, CM and so on. Study outcome modules which provide efficacy

The template varies from study to study depending on protocol specifications.

Paper based CRF:

It is a traditional way of capturing data. Size of CRF varies with the study.

e-CRF:

it is usually large in size, the data captured in a computerized way hence, it is called as electronic case report form which can be archived, stored in easy way.

Importance of e-CRF

As it is mostly preferred to use due to the update in technology & during this pandemic one can access these forms easily

It has many advantages, some of them are of following

✓ Less time consuming / less efforts

✓ Encourage multicentric studies

✓ Errors can be reduced by auto queries

✓ Can link the data easily & quickly with previous forms

Conclusion:

The ultimate aim of designing CRF is to collect accurate, valid & consistent data which results in submission to regulatory authorities (India- CDCSO) & its acceptance.

It would reduce the time and effort to conduct clinical trials

Sound SAP is a tool used to judge the adequacy of CRF

CRF templated are also used to avoid future amendments

CRF GUIDELINES will contribute in designing CRF very well.

You can have a look on sample CRF by the link mentioned below

Microsoft Word - 16.1.2-sample-case-report-form.doc (fda.gov)

BY

Salendra Divya Yadav (ID-81/0521)

M.Sc. biotechnology.

&

Mehnaaz Alam (ID-69/220)

Pharm D