Types of Discrepancies

RDC Onsite has two types of discrepancies:

• System-generated discrepancies
• Manual discrepancies

You can choose to resolve discrepancies as they are raised, or you can defer their resolution for later.

For more information, see:

• System-Generated Discrepancies
  
• Manual Discrepancies
  

System-Generated Discrepancies

System-generated discrepancies are those discrepancies that are automatically created by RDC Onsite. These discrepancies alert you to a possible problem with a response value, or a group of response values.

Your sponsor builds edit checks into the study database. RDC Onsite executes these edit checks and raises discrepancies at various points in the data entry process, including when you update data in a CRF, save a CRF, or validate a patient. In addition, RDC Onsite creates discrepancies during complex edit checks executed on a nightly basis.

There are two types of system-generated discrepancies:

• Univariate (simple)
• Multivariate (complex)

For more information, see:

• Univariate Discrepancies
  
• Multivariate Discrepancies
  

Univariate Discrepancies

A univariate discrepancy, which is also called a simple discrepancy, is a discrepancy that depends on the value of a single data point. For example, demographics such as gender, age, weight, and birthdate are values with a single data point.

When you enter data into a field and then exit from that field (by pressing the Tab key or clicking another field), RDC Onsite checks the data you entered. If the data is not valid for the field, RDC Onsite raises a univariate discrepancy. For example, if the current study is for patients older than 50 years of age and you enter an age of 40, RDC Onsite raises a univariate discrepancy to alert you to the problem.

Univariate discrepancies typically relate to the format of the data entered, or to a value that does not meet pre-defined rules for the field. You can either resolve the discrepancy immediately, or allow the discrepancy temporarily and resolve it later.

Multivariate Discrepancies

A multivariate discrepancy, which is also called a complex discrepancy, is a discrepancy that is dependent on two or more data points. These data points can be within a single CRF or across multiple CRFs and visits.

RDC Onsite raises multivariate discrepancies in the following cases:

• Save a CRF. When you save a CRF by selecting Save Complete, RDC Onsite validates the patient data. If data is missing or if data does not correlate across CRFs, RDC Onsite raises a multivariate discrepancy.
• Validate a patient. Upon completion of data entry for a visit, RDC Onsite validates the data. If values do not correlate across CRFs, RDC Onsite raises a multivariate discrepancy.
• Run regular batch validation. If patient data is not validated upon completion of data entry for a visit, nightly batch validation ensures that discrepancies ordinarily raised by patient validation are detected. Batch validation may also execute complex edit checks that are too time-consuming for an online session.

Manual Discrepancies

A manual discrepancy is a discrepancy that is generated by a user, rather than by RDC Onsite. You can add a manual discrepancy to a CRF section or to a field. You can resolve discrepancies as they are raised, or defer their resolution for later.

Typically, CRAs and data managers enter manual discrepancies (or queries) and route them to site users or other user groups for a response. Investigators and other site users may also create manual discrepancies. However, to enter a manual discrepancy, you must be assigned either update or update discrepancies privileges.

If you have the appropriate privileges, you can enter the following types of manual discrepancies:

• Manual field discrepancies
• Manual section discrepancies
• Manual internal discrepancies

For more information, see:

• Manual Field Discrepancies
  
• Manual Section Discrepancies
  
• Internal Manual Section Discrepancies
  

Manual Field Discrepancies

You can enter a manual discrepancy in association with a specific response field in a CRF. Note that only one manual discrepancy can be associated with a response field regardless of discrepancy status.

RDC Onsite processes manual field discrepancies as follows:

• You enter a manual discrepancy against a response field in the CRF.
• During the study, you resolve this manual discrepancy.
• Once the manual discrepancy is resolved, RDC Onsite lets you add a second manual discrepancy to the same response field. When you save the second manual discrepancy, RDC Onsite overwrites the first resolved manual discrepancy with the second discrepancy because only one manual discrepancy can be associated with a response field regardless of discrepancy status.
• You can continue to enter and resolve discrepancies for the same response field. RDC Onsite overwrites the previous resolved discrepancy with the new one you add.

Note:

The discrepancy history maintains a complete audit for the discrepancy, even when RDC Onsite overwrites previously entered and resolved discrepancies.

Manual Section Discrepancies

You can enter one or more discrepancies in association with CRF sections. You can use a section discrepancy to communicate CRF-related issues among site personnel, data managers, and monitors. Unlike a field discrepancy, you can associate multiple discrepancies with a CRF section.

Internal Manual Section Discrepancies

Section discrepancies can be routed to an internal or hidden status. If your discrepancy management system is configured to use the hidden status, you can create a manual section discrepancy, and route it to another user group with an internal status. It is hidden from other user groups who need not be involved in the communication. Typically, this is configured for use by various user groups internal to the sponsor or CRO, not by site users.