Contents

Purpose

Record study medication administration. Use a separate line for each medication and for each non-consecutive dose administration. Examples:

Oral daily agent:
Enter the start date of the cycle and then enter the date of last dose in the stop date field of the cycle. Note: start and stop times are not necessary for oral agents.

If the daily dosing is interrupted, enter the stop date, and on another line enter the start date if resumed during the same cycle. Enter the missed doses on the Missed Dose eCRF.

Agent administers on Days 1-5 weekly every 28 days
Enter four lines, one for each consecutive weekly doing.

If the daily dosing is interrupted, enter the stop date, and on another line enter the start date if resumed during the same cycle. Enter the missed doses on the Missed Dose eCRF.

Agent administer on Days 1, 3, 5 every 21 days
Three line entries are required

Continuous IV administration >24 hours
Enter start date and time of the infusion and when the infusion is completed (e.g., after 72 hours), enter the stop date and time.

Two IV agents are administer, one on Day 1 and the other on Days 1 and 15
Enter the two agents on separate lines for Day 1 and then on the third line, enter the Day 15 administration of the second drug.

Study Medication Administration eCRF

 

Field Name

Description / Instructions

Format

Visit Date(m)

Enter the date the course started.

DD-MMM-YYYY

Day in Course(d)

Indicates the day since the beginning of course initiation. Derived from the course initiation start date.

5 digits

Start Date(m)

Enter the date the medication was administered.

DD-MMM-YYYY

Start Time

For IV infusions only: Enter the start time of the infusion.

HH(24):MM

Stop Date

Enter the date the medication was discontinued.

DD-MMM-YYYY

Stop Time

For IV infusions only: Enter the stop time of the infusion.

HH(24):MM

Medication(m)

Select a medication from the list.

Note: The medication pick list incorporates all study medications, including pre and post medications specified in the protocol as part of the treatment. These medications should be documented in this case report form and NOT in the Concomitant Measures / Medications form.

Use pick list.

Planned Dose Level(m)(c)

Enter the amount of medication (a number) that was planned to be given for the dose level.
It is not appropriate to record the dose level number such as "dose level 1". If the dose level is 100 mg/m2, then enter 100 for the dose level. The mg/m2 will be captured in the Planned UOM field.
For dose levels that are expressed with scientific exponential units using powers of 10 such as vaccines and viral particles, enter as x10E. For example, dose level description is 2 x 106 PFUs, the dose level would be 2x10E6 and the PFUs would be noted in the Planned UOM (Units of Measurement) field.

Note: for non-CTEP studies, this field may be removed.

8 digits & 3 decimals

Planned UOM(m)(c)

Select the Planned Dose Level unit of measurement.

Note: for non-CTEP studies, this field may be removed.

Use pick list.

Planned Schedule(m)(c)

Select the schedule of medication administration as indicated in the protocol.

Note: for non-CTEP studies, this field may be removed.

Use pick list.

Planned Route(m)

Select the route from the list.

Use pick list.

Actual Total Dose(m)

Enter the total actual dose given for the medication name entered above for the time period encompassed by the duration. See Actual UOM below for the units of measure of the actual dose.

Note: In the case of medications (such as vaccines and viral particles) where the dose is expressed with scientific exponential units using powers of 10, record (for example) 106 as 1X10E6.

8 digits & 3 decimals

Actual Dose UOM(m)

Select the Actual Dose Level unit of measurement.

Use pick list.

Lot #

Enter the Lot Number for the medication supply.

24 characters

Duration(m)

Enter the duration calculated from the start date/time and stop date/time.

Note: for non-CTEP studies, this field is not mandatory.

6 digits & 2 decimals

Duration UOM(m)

Select the units of measurement so that the duration can be derived.
DY - Days
HR - Hours
MN - Minutes
MO - Months
Wk - Weeks

Use pick list.

Legend: (d) derived field, (m) RDC mandatory, (c) for CTEP reporting only.

Validations

Code

Description

Resolutions

SD01, SD03

Start Date and/or Stop Dare are/is in the future.

Enter a date earlier than or equals to the current date.

SD04

Stop Date/Time is prior to Start Date/Time.

Correct the Start Date/Time or Stop Date/Time.

SD05

Duplicate Medication records exist.

A unique entry for Medication, Start Date/Time and Stop Date/Time is required.

SD06, SD07,
SD08, SD09

Overlapping start and stop dates/times for the same medication.

Review the medications in question and their respective start and stop dates/times.

SD10

Start Time or Stop Time is missing.

Both Start and Stop Time are required or optional.

Derivations

Code

Field Name

Description

SD1001

Day in Course

Derived from the respective course initiation start date.

 

Study Medication Missed

 

Field Name

Description / Instructions

Format

Day in Course (d)
Indicates the day since the beginning of course initiation. Derived from the course initiation start date.
5 digits
Start Date of Missed Medication (m)
Enter the start date the medication was not administered.
DD-MMM-YYYY
Start Date of Missed Medication (m)Enter the stop date the medication was not administered.DD-MMM-YYYY
Medication (m)Select the name of the missed medication.Use pick list
Total Missed Dose Amount (m)
Enter the actual amount of medication missed for the date entered above.

 

Note: In the case of medications (such as vaccines and viral particles) where the dose is expressed with scientific exponential units using powers of 10, record (for example) 107 as 1 and select 10E7 as the Missed Amount UOM.

8 characters
UOM (m)Select the Missed Dose Amount unit of measurement.Use pick list
Reason for Missed Dose (m)Select the reason the medication was missed.Use pick list
Explain 'Other' Reason Missed
Enter an explanation for selecting “Other” for Reason for Missed Dose.
30 characters

Legend: (d) derived field, (m) RDC mandatory, (c) for CTEP reporting only.

Validations

Code

Description

Resolutions

SD13Stop Date/Time for Study Medication Missed is before Start Date/Time.Verify that Start Date/Time is before Stop Date/Time.
SD14Actual Total Dose is not valid numeric value.Enter valid numeric value.
SD15Dose Level is not valid numeric value.Enter valid numeric value.

Derivations

Code

Field Name

Description

SM1001
Day in Course
Derived from the respective course initiation start date.