Short Title/Acronym

Chief Investigator:

Sponsor Number: XX/XXXX

EudraCT Number: XXXX-XXXXXX-XXX

Name of site:

CRF Version Number:X, XX/XXX/XXXX

Patient Initials Subject No.

Screening No. Centre No.

CRF Completion Instructions

General

Complete the CRF using a black ballpoint penand ensure thatall entries are complete and legible.

Avoid the use of abbreviations and acronyms.

The CRF should be completed as soon as possible after the scheduled visit.

Do not use subject identifiers anywhere on the CRF, such as name, hospital number etc., in order to maintain the confidentiality of the subject. Ensure that the header information (i.e. subject’s initials and ID number) is completed consistently throughout the CRF. Missing initials should be recorded with a dash (i.e. D-L).

Each CRF page should be signed and dated by the person completing the form.

The ‘completed by’ Name in the footer of each page must be legible and CRFs should only be completed by individuals delegated to complete CRFs on the Site Delegation log (and signed by the PI).

Ensure that all fields are completed on each page:

· If a test was Not Done record NDin the relevant box(es)

· Where information is Not Known write NKin relevant box(es)

· Where information is not applicable write NAin the relevant box(es)

Corrections to entries

If an error is made, draw a single line through the item, then write the correct entry on an appropriate blank space near the original data point on the CRF and initial and date the change.

Do NOT

· Obscure the original entry by scribbling it out

· Try to correct/ modify the original entry

· Use Tippex or correction fluid

Medications taken by the subject during the trial should be recorded on the “Concomitant Medications Log” using the generic name whenever possible, except combination products which will be recorded using the established trade name. All non-IMPs mentioned in the protocol should also be recorded on the “Concomitant medication Log” for the duration of the trial.

Verbatim Adverse Event terms (initial medical term) should be recorded as the final diagnosis whenever possible.

Complete all dates as day, month, year i.e. 13/NOV/2008. Partial dates should be recorded as NK/NOV/2008.

All timesare to be recorded in 24 hour format without punctuation and always use 4-digits; i.e. 0200 or 2130. Midnight is recorded as 0000.

Weights should be recorded to the nearest 0.1 kg.

Source documents such as lab reports, ECG reports etc. should be filed separately from the CRF (if not in the medical notes) for each subject and be signed and dated by a delegated Investigator as proof of review of the assessment during the trial. Questionnaire should be considered as the CRF appendices (except standard approved questionnaire e.g. EQ-5D)

If a subject prematurely withdraws from the trial a single line must be drawn across each uncompleted page to correspond with the last visit of the subject as mentioned on the “Trial Completion” page.

The protocol deviation/violation/serious breach log should be used to record comments relating to each CRF visit that cannot be captured on the page itself. This includes reason for delayed or missed protocol visits or trial assessments, unscheduled visits etc.

The Chief Investigator (for lead site)/Principal Investigator is responsible for the accuracy of the data reported on the CRF. The CI/PI must sign and date the Principal Investigator’s Sign Off page to certify accuracy, completeness and legibility of the data reported in the CRF.

Serious Adverse Events (SAEs)

SAEs should be faxed within 24 hours of the site being aware of the event using the trial specific SAE report form to 020 3108 2312 or preferably emailed to sae@ucl.ac.uk

Storage

CRF documents should be stored in a locked, secure area when not in use where confidentiality can be maintained. Ensure that they are stored separately to any other documents that might reveal the identity of the subject.

VISIT 1 (SCREENING)demographic data

Date: 2016-03-03; view: 1459