Download Section 12. Data Collection

termination, update the response in Item 4 to “no – permanently discontinued” and record the
date the reason first met criteria for permanent discontinuation.
Example: After reporting a general feeling of malaise, a participant’s safety lab results at
her Day 21 visit on 13Ju15 indicate Grade 3 decreased platelets. An AE, deemed not
related, is reported and a product hold is initiated this visit. This AE is ongoing at her Day
28 visit and item 4 on the PH log CRF is updated to ‘no – hold continuing at the Day 28
visit” with the date of 20Jul15. Repeat follow-up testing on her day 31 visit indicates that
the AE has increased in severity to grade 4 and a new AE is completed to document. Item 4
on the PH log CRF should also be updated to ‘no – permanently discontinued’ with a date
of 23Jul15, dated, initial and refaxed.

If “no – permanently discontinued” is marked in Item 4, record the date that the reason in Item
2 met criteria for permanent discontinuation. This date could fall anytime between the
participant’s enrollment visit up through her Termination date.
12.5 Case Report Forms
The MTN-027 CRFs are posted both on the ATLAS webpage for downloading and printing.
MTN-027 SSP Manual
Section 12
Version 1.0
15 May 2015
Page 12-21