Baseline Patient Forms

Transcription

1 Revision of 06/14/2016 Page 1 of 7 CKD PILOT STUDIES Forms Completion Schedule - COMBINE Non-Patient Forms In order to make a clinical site ready to enroll F09 Clinical Center F10 Study Personnel Review items needed for start-up Consent visit n/a n/a Baseline Patient Forms Informed Consent (not entered into database. Includes Biorepository consent. Fax the de-identified signature page only to the DCC and write the PID and alphacode in the middle of the page.) Participant Information (See MOP this is not entered into database) Screening Visit (S0 visit) F107 Screening F115 Local Lab Serum and Plasma Screening Results F116 Local Lab Whole Blood Results F121 Local Lab Pregnancy Test Result 3 Visit At some time between Screening and B0 Visit -- Report Name Rpt Ready for Baseline (B0) Placebo Report Rpt Initial Baseline Bottle Number Assignment Report At some time between Screening and B1 Visit F122 Co-Morbidity and Medical History F123 Baseline Demographics, Employment, and Income MRI Forms At Anytime during Baseline F291 Cardiac and BOLD Renal MRI Submission (done for those who consented to MRI and was eligible for MRI based on the screening form) Run the Ready for Baseline (B0) Placebo Report. If the participant is eligible, proceed with B0.

2 Revision of 06/14/2016 Page 2 of 7 B0 Visit Rpt 3 F285 F148 B1 Visit 3 F149 F285 F300 F301 F329 F330 F331 F335 Baseline Placebo Bottle Assignment Visit GI Symptoms and Other AE s Baseline Initial Pill Dispensing Visit Baseline Pill Count GI Symptoms and Other AE s Biorepository Serum and Plasma Mailing Biorepository Urine Mailing FGF23 and R01 Sample Drawn and Stored FGF23 and R01 Sample Mailing (batched sample-shipped once each month) Spectra Lab Serum/Blood/Spot Urine Mailing Spectra Lab 24-Hr Urine Mailing Forms Completed by Central Labs (Spectra and UW FGF23Core) at B1 B2 Visit 3 F149 F285 F300 F301 F329 F330 F331 F335 Visit Baseline Pill Count GI Symptoms and Other AE s Biorepository Serum and Plasma Mailing Biorepository Urine Mailing FGF23 and R01 Sample Drawn and Stored FGF23 and R01 Sample Mailing (batched sample-shipped once each month) Spectra Lab Serum/Blood/Spot Urine Mailing Spectra Lab 24-Hr Urine Mailing Forms Completed by Central Labs (Spectra and UW FGF23Core) at B2 F361 Spectra Lab Whole Blood / HgbA1c Results Forms Completed by MRI Cores F701 Core Receipt of Cardiac MRI Form F702 Core Receipt of BOLD Renal MRI Form F711 Cardiac MRI Core Incidental Findings F712 BOLD Renal MRI Core Incidental Findings F721 Cardiac MRI Core Results F722 BOLD Renal MRI Core Results

3 Revision of 06/14/2016 Page 3 of 7 Reports can be run at anytime during Baseline Report Name Rpt Ready to Randomize Report Rpt On-Line Randomization Report As Needed during Baseline F163 Baseline (Pre-Randomization) Drop-out (includes drop-out for unanticipated pregnancy) F403 Re-Enrollment of a Previously Enrolled Participant F410 Late Consent for Biorepository F411 Withdrawal of Consent for Biorepository F511 Hospitalization Notification F512 Hospitalization Details F522 Details of SAEs that are Not Hospitalizations or Deaths F531 Death Notification F532 Detailed Death F540 Event Information Sent to the DCC F549 Vascular Access Created/Placed F550 Initiation of Chronic Dialysis or Transplant F551 Baseline/Follow-Up Pregnancy Reported Rpt Lanthanum Baseline Bottle Number Assignment (if baseline pills are lost) Rpt Nicotinamide Baseline Bottle Number Assignment (if baseline pills are lost) If the Ready to Randomize Report shows that participant is eligible for the study, proceed to the Randomization Screen to randomize the participant.

4 Revision of 06/14/2016 Page 4 of 7 Follow-up Patient Forms COMBINE Follow-up Visit: F0 (first post randomization visit) If FV0 is on same day or within 1 week of the B2 and there were no hospitalizations or other SAE, then only complete F248. If the FV0 is more than 1 week after the B2 visit and/or there was a hospitalization or other SAE, then complete the following forms: 3 Visit F248 Follow-up Initial Pill Dispensing Follow-up Visit: F1 3 Visit Form Form Completed by Central Labs (Spectra and UW FGF23Core) at F1 Follow-up Visit: F2 3 Visit Form Completed by Central Labs (Spectra and UW FGF23Core) at F2 Follow-up Visit: F3 3 Visit F300 Biorepository Serum and Plasma Mailing F301 Biorepository Urine Mailing F335 Spectra Lab 24-Hr Urine Mailing

5 Revision of 06/14/2016 Page 5 of 7 Forms Completed by Central Labs (Spectra and UW FGF23Core) at F3 Follow-up Visit: F6 Quarterly Urine Scale Calibration 3 Visit (completed at this visit only if new bottles are dispensed) F300 Biorepository Serum and Plasma Mailing F301 Biorepository Urine Mailing F335 Spectra Lab 24-Hr Urine Mailing Forms Completed by Central Labs (Spectra and UW FGF23Core) at F6 F361 Spectra Lab Whole Blood / HgbA1c Results Follow-up Visit: F9 3 Visit (completed at this visit only if new bottles are dispensed) Forms Completed by Central Labs (Spectra and UW FGF23Core) at F9 Follow-up Visit: F11 3 Visit (completed at this visit only if new bottles are dispensed)

6 Revision of 06/14/2016 Page 6 of 7 Follow-up Visit: F12 3 Visit F289 Participant End of Study Questionnaire F291 Cardiac and BOLD Renal MRI Submission (done for those who consented to MRI and was eligible for MRI based on the screening form) F300 Biorepository Serum and Plasma Mailing F301 Biorepository Urine Mailing F335 Spectra Lab 24-Hr Urine Mailing F475 Study Closeout completed by PI Forms Completed by Central Labs (Spectra and UW FGF23Core) at F12 F361 Spectra Lab Whole Blood / HgbA1c Results Forms Completed by Central MRI Cores F701 Core Receipt of Cardiac MRI Form F702 Core Receipt of BOLD Renal MRI Form F711 Cardiac MRI Core Incidental Findings F712 BOLD Renal MRI Core Incidental Findings F721 Cardiac MRI Core Results F722 BOLD Renal MRI Core Results As Needed during Follow-Up F250 Between Visit Phone Medication Change F286 Symptoms/Adverse Events Reported on Phone Calls or at Extra Non-Protocol Visits F380 Local Lab Adverse Event Recheck Results F410 Late Consent for Biorepository F411 Withdrawal of Consent for Biorepository F511 Hospitalization Notification F512 Hospitalization Details F522 Details of SAEs that are Not Hospitalizations or Deaths F531 Death Notification F532 Detailed Death F540 Event Information Sent to the DCC F549 Vascular Access Created/Placed Form F550 Initiation of Chronic Dialysis or Transplant F551 Post-Screening Pregnancy Reported

7 Revision of 06/14/2016 Page 7 of 7 F582 Study Medication Discontinuation Recommended by Lab Values F583 Reaction to Furosemide F593 Request for/report Unblinding Forms Completed by UW FGF23Core F364 UW Core Lab Serum FGF23 Results F365 UW Core Lab Special Lab Results Completed by CKD Event Review Committee F612 Event Review Committee Hospitalizations Review F622 Event Review Committee SAE s that are not hospitalizations or Death Review F632 Event Review Committee Death Review F663 Review Study Medication Unblinding