Table 1 Overview of the standardized content of a CRF used for pharmacological studies according to the consensus. Measurements at each visit are graded according to essential to collect (A) or highly recommended (B).
| Â | Screening | Baseline | Week 2 | Week 4 | Week 8 | Week 12 = End | Week 16 Follow up |
|---|---|---|---|---|---|---|---|
TSCHQ | A | Â | Â | Â | Â | Â | Â |
Otological Examination | A | Â | Â | Â | Â | Â | Â |
Medical history | A | Â | Â | Â | Â | Â | Â |
Audiometry | A | A | Â | Â | Â | B | Â |
Loudness match | Â | B | Â | Â | Â | B | Â |
Pitch match | Â | B | Â | Â | Â | B | Â |
Maskability | Â | B | Â | Â | Â | B | Â |
Residual Inhibition | Â | B | Â | Â | Â | B | Â |
THI | A | A | A | A | A | A | A |
TBF 12 | B | B | B | B | B | B | B |
Tinnitus Numeric Rating Scales | A | A | A | A | A | A | A |
BDI | B | B | B | B | B | B | B |
WHOQOL | B | B | B | B | B | B | B |
CGI (change) | Â | Â | A | A | A | A | A |
Concomittant medication | A | A | A | A | A | A | A |
Adverse Events | Â | Â | A | A | A | A | A |
Comorbidity | A | A | A | A | A | A | A |