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

Landgrebe et al. BMC Medical Informatics and Decision Making 2010 10:42   doi:10.1186/1472-6947-10-42