Participant Final Status Form (PFS)

Instructions for Completing Form

Participant Group:This form is completed for allrandomized participantsin the MOTOR study who have either completed the study protocol or are unable to complete the study protocol.

When completed:This form should be completed each time a participant wholly or partially withdraws consent, or is wholly or partially lost to follow-up.

Who completes:Motor Staff trained by the Study Coordinator for data collection.

Other Documents:No additional forms are needed.

Form Instructions:

Header:

  • ID: Attach Participant ID label, or record ID number.
  • Name:Record the participant name (this is not data entered).
  • Visit:Visit # is always 05.
  • Seq#:Seq # is always 01.
  • Staff ID:Record initials of staff collecting PFS data.
  • Date:Record date of PFS data collection

Special Instructions:

  • The form should be completed for all randomized participants who have either completed the study protocol or who will not be able to complete the study protocol.
  • Each participant should have 1 PFS form completed when the protocol is completed.

Instructions on How to Complete Form Items:

Question 1. Date of study completion:

Enter the MM/DD/YYYY formatted date of the participant’s completion of, or inability to complete, study protocol.

Question 2. Did the participant complete the entire study protocol?

If the participant has completed the entire course of the MOTOR study, per protocol, circle “Y” and you are done with this form, unless you wish to write comments (Question 5). Questions 3 and 4 do not apply. To have completed the entire course means that all post partum data collection is complete. This includes data collection on the LDF, NBF, NIC, PHF, POS, and PDE, and if participant was randomized to delayed treatment, treatment was competed. Note: a participant can complete the study if some lab specimens were not able to be collected (i.e. placental samples).

If the participant has not completed the entire course of the study per protocol, circle “N” and continue to the next question.

Question 3. Reason for non-completion of study protocol

From choices “A” to “G”, circle one primary reason for non-completion of the study protocol.

If the participant does not complete study protocol because shehas withdrawn consent, circle “A”.

If non-completion is due to death or other SAE, circle “B” andenter the death or eventdate in MM/DD/YYYY format. If this was a death, indicate whether participant and/or fetal death. Also, complete SAE forms (required).

If the participant does not complete study protocol and is lost to follow-up, circle “C”. This code is used to indicate participant has moved, making participant contact impossible; however, medical records are obtainable for primary outcome data.

If the participant does not complete study protocol because she delivers in a non-study hospital,

circle “D”.

If the participant does not complete study protocol because she refuses or is unable to participate in some postpartum evaluations, circle “E”.

If non-completion is because the Site is unable to complete data collection (i.e., postpartum specimen collection). circle “F”.

If the participant does not complete study protocol for reasons not listed, circle “G”, and specify the Other reason for non-completion in the space provided.

Question 4. Please indicate which study procedures or data collection were not performed or obtained, indicate all that apply.

If missing primary outcome data, LDF and/or NBF, check ‘a’.

If postpartum OB samples aremissing (MBF and/or POS missing), check ‘b’.

If participant refuses or is unable/unwilling to have the postpartum dental examination (DDES missing), check ‘c’.

If participant’s dental interview is missing (DPE missing).

If participant refuses delayed treatment, if Group 2 (DTF missing), check ‘e’.

If participant requests samples destroyed, check ‘f’.

Question 5. Comments:

Circle “Y” if there are additional comments concerning study completion or non-completion for this participant and explain in the space provided. Attach additional pages if necessary.

PFS QxQ / October 4, 2004Page 1 of 2