Advertisement
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).
| Screening | Baseline | Week 2 | Week 4 | Week 8 | Week 12 = End |
Week 16 Follow up | |
|---|---|---|---|---|---|---|---|
| TSCHQ | A | ||||||
| Otological Examination | A | ||||||
| Medical history | A | ||||||
| Audiometry | A | A | B | ||||
| Loudness match | B | B | |||||
| Pitch match | B | B | |||||
| Maskability | B | B | |||||
| Residual Inhibition | B | B | |||||
| 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) | A | A | A | A | A | ||
| Concomittant medication | A | A | A | A | A | A | A |
| Adverse Events | A | A | A | A | A | ||
| Comorbidity | A | A | A | A | A | A | A |
