Case Report Form (CRF)

Case Report Form (CRF):

A case report form is an optical, printed or electronic document which is designed to record all the protocol required information to be reported to the sponsor on each trial subject.

Types of CRF’s:

1. Paper CRF’s and 

2. Electronic CRF’s

Types of queries in paper CRF’s:

A query is an error generated when there is a problem or inaccuracy with the data. There are mainly 3 types of queries in paper CRF’s. They are as follows:

1. Answered query

2. Reissued query and

3. Closed query

Answered query:

Whenever there is an error in the data entered, CDM team will ask for the justification or clarification regarding that error to the site/Investigator/CRA and then closes the query if the justification is reasonable after verifying various documents. The query which is justified or clarified or answered by the site but not closed yet is called an answered query.

Eg: As per protocol the age of subject to participate in a trial is 18-85 but the data entered is below 18 or above 85 then the CDM will raise a query regarding this to the site. If the site justifies or replies to that query and the query is not closed yet. Then this query is considered as Answered query.

Only site, either Investigator or a CRC will answer the queries.

Reissued query:

When the original query has not been adequately resolved by the investigator/Site or if there is a need for additional information to resolve an issue, the CDA must re-issue the query to receive appropriate clarification. Such queries are called as re-issued queries. All re-issued queries must have reference the original query to aid resolution. 

Eg: If there is a protocol deviation, CDM will raise a query to the site to know the reason for deviation, and if the justification or clarification given by site is not accepted by the CDM he will raise the same query once again for further clarification. This type of query is a re-issued query.

CDM, Coder, CRA, PV specialist, TMF specialist, Lab Reconciliation specialists can Re-issue a query but only after verifying all the required documents. 

Closed query:

When the errors in the data are justified or clarified with accurate information which is required or the data is updated then the CDM closes the query. This type of queries are called as closed queries.

Eg: If the gender in DM form is marked as Male and Pregnancy is marked as Yes this will be a query and CDM will raise the query. Then the site updates the Gender in DM form as female this justifies the data entered as valid, then CDM will closes the query.

CDM, Coder, CRA, PV specialist, TMF specialist, Lab Reconciliation specialists can close a query. 

Types of queries in eCRF’s:

All the queries are similar as of in paper CRF’s. In addition to them it also contains Auto-Query or Open Query.

Auto Query/Open Query:

An Auto Query is a system generated query when there is an error or mistake in the data entered. Whenever an auto-query is generated the CRC/Site will correct the data and will be asked for Edit Check Specification then the system will close it.

Eg: If the AE start date entered is before the ICF signed date, then the system will automatically raise a query as AE start date should be only after or equal to the ICF signed date. After updating ICF date or AE start date correctly the query will again close automatically.

By-

Sairam Polishetti 

B.Pharm

Teegala Krishna Reddy College Of Pharmacy