Source data verification

To assess the accuracy and completeness of data recorded by collaborating centres onto report forms, source data verification is used. Industry-sponsored trials typically use extensive source data verification. It is widely accepted, however, including by the ICH GCP Guideline (see Section 7.3) and the US Food and Drug Administration, that trials

MRC TE08: A Study of CT Scan Frequency in Stage I NSGCT

Patient : ABC Date of birth 01/07/75

Trial Number: 1234 Date Registered 10/03/02

Date of orchidectomy 15/02/02 Hosp No: 12345678

Allocated treatment: 5 CT Scan Schedule Follow-up investigations and forms required for this patient and approximate dates:

Date

Investigations/forms

18/03/02 AFP, HCG, LDH, chest X-ray, clinical examination

17/04/02 AFP, HCG, LDH, chest X-ray, clinical examination

17/05/02 AFP, HCG, LDH, CHEST AND ABDOMEN CT SCAN, clinical examination

17/06/02 AFP, HCG, LDH, chest X-ray, clinical examination

17/07/02 AFP, HCG, LDH, chest X-ray, clinical examination

17/08/02 AFP, HCG, LDH, CHEST AND ABDOMEN CT SCAN, clinical examination, TE08/1 form to trials office

AFP, HCG, LDH, chest X-ray, clinical examination AFP, HCG, LDH, chest X-ray, clinical examination

AFP, HCG, LDH, CHEST AND ABDOMEN CT SCAN, clinical examination

17/12/02 AFP, HCG, LDH, chest X-ray, clinical examination

16/01/03 AFP, HCG, LDH, chest X-ray, clinical examination

15/02/03 AFP, HCG, LDH, CHEST AND ABDOMEN CT SCAN, clinical examination, TE08/2 form to trials office

AFP, HCG, LDH, chest X-ray, clinical examination

AFP, HCG, LDH, chest X-ray, clinical examination

AFP, HCG, LDH, chest X-ray, clinical examination

AFP, HCG, LDH, chest X-ray, clinical examination

AFP, HCG, LDH, chest X-ray, clinical examination

15/02/04 AFP, HCG, LDH, CHEST AND ABDOMEN CT SCAN, clinical examination, TE08/3 form to trials office

AFP, HCG, LDH, chest X-ray, clinical examination

AFP, HCG, LDH, chest X-ray, clinical examination

AFP, HCG, LDH, chest X-ray, clinical examination

AFP, HCG, LDH, chest X-ray, clinical examination, TE08/4 form to trials office

This schedule has been designed to be used as a guide and to help the clinician in charge in forecasting which examinations are needed according to the protocol. It is not an official document relating to the follow-up of this patient and clinical discretion should guide exact timings. IF THE PATIENT RELAPSES IT IS IMPORTANT THAT THE LDH SHOULD BE MEASURED ALONG WITH THE AFP AND HCG and the TE08/5 relapse form should be filled in and sent to the trials unit as soon as possible.

Fig. 8.1 Example of a schedule of dates from a randomized trial in testicular cancer.

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