Contents

Purpose

Record the patient's seizure activity details. This CRF is only used if the BTTC protocol specifically requires detailed seizure activity. See BTTC protocol for guidance.

Note: For most BTTC protocols, seizures will only be recorded as an adverse event on the Adverse Event CRF.

Seizure Activity Summary eCRF

 

Field Name

Description / Instructions

Format

Visit Date(m)

Enter the date the form was completed (i.e. the date information was gathered).

DD-MMM-YYYY

Contact DateEnter the date the patient was contacted about Seizure Activity.

DD-MMM-YYYY

Contact TimeEnter the time the patient was contacted about Seizure Activity.

HH(24):MM:SS

Contact Type

Select how the information was obtained:
1. Telephone contact with patient
2. Telephone contact with patient's family
3. Telephone contact with patient's local physician
4. Social Security Death Index (SSDI)
5. Clinic Appointment
6. Mail contact with the patient
7. E-Mail contact with the patient
8. Other
9. Email from Family
10. Email From Doctor's Office
11. Mail Contact from Local MD(s)
12.Home Phone
13. Cell Phone
14. Office Visit

Use pick list.

Has the patient experienced any seizure activitySelect the term to signify whether a patient has experienced seizure activity as described in the Education Sheet from the pick list:

  • NO

  • YES

  • N/A

  • UNKNOWN

Use pick list.

Contact ResultSelect the result of an effort to contact a patient from the pick list:

  • SPOKE TO FAMILY MEMBER

  • SPOKE TO PATIENT

  • UNABLE TO CONTACT PATIENT

Use pick list.

Is the participant compliant?Select the term to signify whether the participant is compliant with protocol intervention(s) per telephone conversation from the pick list:

  • NO

  • YES

  • N/A

Use pick list.

MDASI Performed?Select the term to signify whether an MD Anderson Symptom Inventory (MDASI) self-administered questionnaire was given to a patient from the pick list:

  • NO

  • YES

  • N/A

Use pick list.

Date of Seizure ActivityEnter the date of patient seizure activity as described in the Education Sheet.

DD-MMM-YYYY

Time of Seizure ActivityEnter the time of patient seizure activity as described in the Education Sheet.

HH(24):MM:SS

Pre Seizure Activity

Delineation of a patient behavior that occurred before the appearance of seizure activity.
Select the answers for each question about patient's Pre Seizure activity from the pick list:
Yes - Yes
No - No

Use pick list.

Legend: (m) RDC mandatory

Validations

Code

Description

Resolutions

 

 

 

Seizure Activity Summary (Cont...) eCRF

 

Field Name

Description / Instructions

Format

Seizure DescriptionDescriptive classification to describe signs and/or symptoms that occurred during a seizure.
Select the answers for each question about patient's Seizures Description from the pick list:
Yes - Yes
No - No

Use pick list.

Post Seizure ActivityIdentification of care-related activity that occurred at the time or following a patient seizure.
Select the answers for each question about patient's Post Seizures activity from the pick list:
Yes - Yes
No - No

Use pick list.

EEG done? If yes, submit reportSelect the term to signify whether a patient had an electroencephalography study of the brain completed from the pick list:
Yes - Yes
No - No

Use pick list.

Date of EEGEnter the date of electroencephalography for a patient.

DD-MMM-YYYY

Time of EEGEnter the time of electroencephalography for a patient.

HH(24):MM:SS

Diagnosis of seizureSelect the term to define the extent of seizure activity in an individual from the pick list:

  • COMPLEX PARTIAL SEIZURE

  • PARTIAL SEIZURE WITH SECONDARY GENERALIZED SEIZURES

  • SIMPLE PARTIAL SEIZURE

Use pick list.

Simple Partial SeizuresDelineation of signs and/or symptoms experienced by a patient having a simple partial seizure.
Select the answers for each question about patient's Simple Partial Seizures activity from the pick list:
Yes - Yes
No - No

Use pick list.

Complex Partial SeizuresTerm to identify signs and/or symptoms associated with a patient's complex partial seizures.
Select the answers for each question about patient's Complex Partial Seizures activity from the pick list:
Yes - Yes
No - No

Use pick list.

Partial seizures with secondarily generalized seizuresTerm to delineate sign(s) and symptom(s) experienced by a patient with a partial seizure with secondary generalized seizure activity.
Select the answers for each question about patient's Partial seizures with secondarily generalized seizures activity from the pick list:
Yes - Yes
No - No

Use pick list.

Legend: (m) RDC mandatory

Validations

Code

Description

Resolutions

 

 

 
Last updated by Blackburn, Katie (NIH/NCI) [C] on Apr 18, 2017