Item
MOD1: Screening to Study Conc. (Page 1-68)
text
Code List
MOD1: Screening to Study Conc. (Page 1-68)
Screening to Study Conc. missing pages
Item
MOD1: Screening to Study Conc. (Page 1-68): Missing pages (if applicable)
integer
Item
MOD2: RLS Rating Scales (page 75-113)
text
Code List
MOD2: RLS Rating Scales (page 75-113)
RLS Rating Scales: missing items
Item
MOD2: RLS Rating Scales (page 75-113): Missing pages (if applicable)
integer
Item
MOD3: Patient Scales (page 114-146)
text
Code List
MOD3: Patient Scales (page 114-146)
Patient Scales (missing pages)
Item
MOD3: Patient Scales (page 114-146): missing pages (if applicable)
integer
Item
SAE1&2: Serious Adverse Experiences (pages 69-72)
text
Code List
SAE1&2: Serious Adverse Experiences (pages 69-72)
Serious Adverse Experiences (missing pages)
Item
SAE1&2: Serious Adverse Experiences (pages 69-72): missing pages (if applicable)
integer
Item
FORMD1: Form D (page 73)
text
Code List
FORMD1: Form D (page 73)
Form D (missing pages)
Item
FORMD1: Form D (page 73): missing pages (if applicable)
integer
Site Monitor´s comments
Item
Site Monitor´s comments (e.g. protocol violations or deviations)
text
Site Monitor´s Name
Item
Site Monitor´s Name
text
Site Monitor´s Signature
Item
Site Monitor´s Signature
text
Date Submitted
Item
Date Submitted
date