CRF DESIGNING

                      CRF DESIGNING

DEFINITION : Case report form (CRF) is a printed ,optical or electronic document to record all protocol required information to be reported to sponser on each trial sub jects as per ICH guidelines .

Source documents first captured information  ,record s are Collected from each participants subject of clinical trial are capture into CRF.

TYPES OF CRF :

 

THREE THINGS BEFORE WORKING ON CRF:

  

TYPES OF ITEMS:

Item questions         control type           item response

1. RADIO      : Single selection [□Yes/ □ No]

Example : Gender :  Male / Female

2. Check box  : used for selecting one or more options

3. Alpha numeric : Series which consists of both numbers & alphabets 

 

4. Pull down :

                       

5. Date of time :  Example : Date of birth : [02/AUG/2010] DD/MMM/YYYY

  Time   : Hr/min,

6. Integer : 

 

                                                                                                            

7. Decimal values :

                                                                      

TYPES OF FORMS : 

 

1. Dynamic form : A form which get triggered based on satisfaction of some criteria

                                   Example : if Gender = Female  then trigger pregnancy form

2. Repeating form    ; Same data points repeated for more than once

Example: Adverse event form, Medication history and concomitant medication forms

3. Add entry : Adding entries to forms which has a repeating sections only some   items are going to be repeated for it .particular assessments.

Example : Medical history form( MH,CM has particular section repeated in add entry)

4. Flat form  : A Form called as flat form is the information which entered once about subject .the form  wount be repeated.

           Example: Demographic form

TYPES OF VISITS :

Dynamic visit : Add of subject  visit at any time based on date of visit

                            Example : if a subject agree s for extention of participation ,extention visits  generated automatically.

Repeating visits : A visit repeated ,undefined visit

                               Example : In oncology trials repeating of visits  end point till death 

Unscheduled visit : A visit scheduled not as per protocol 

                                    Example : subject with complain of adverse event unscheduled visit.

Scheduled visit :  A visit which have been scheduled as per protocol

STANDARD CRF TEMPLATES :

1. Demographic form

2. Adverse event form

3. Vital Signs

4. Inclusion & exclusion

5. Concomitant form

6. Medication History 

7. Pregnancy form

8. ECG form

9. Lab form

10. Disposition form 

                                                                              

                                                    By,

                                                  Heena Ameena 

                                              Pharm D (Intern)                                    Clinosol Research Pvt Ltd