This section may not always Seven Safety Reporting be applicable Investigator Brochure/Summary of Product 7.1 Characteristics and updates 7.2 Serious Adverse Event (SAE) Reports Procedure for randomisation and unblinding/code 7.3 (if applicable) 7.4 Code break envelopes (if applicable) 7.5 Blank SAE forms 7.6 Correspondence Eight Subject Logs and Consent Forms Subject Screening and Enrolment Log, Identification 8.1 Code List 8.2 Signed Informed Consent Forms Nine Equipment (if applicable) 9.1 Calibration Certificates 9.2 Related Correspondence Pharmacy (to be kept in pharmacy department This section may not always Ten whilst study is ongoing if using Pharmacy be applicable Services) 10.1 Delegation of Authority and Signature Form 10.2 Pharmacy Agreement 10.3 Cheque request forms/invoices 10.4 Documentation of shipment 10.5 Sample of labelling 10.6 Instructions for handling of study medication 10.7 Notification of unblinding 10.8 Retrieval of code-break envelopes 10.9 Drug accountability 10.10 Pharmacy correspondence Eleven Local Laboratory (where a Central Laboratory is not used) 11.1 Laboratory Agreement 11.2 Normal Ranges 11.3 Accreditation
Seven Safety Reporting This section may not always be applicable 7.1 Investigator Brochure/Summary of Product Characteristics and updates 7.2 Serious Adverse Event (SAE) Reports 7.3 Procedure for randomisation and unblinding/code (if applicable) 7.4 Code break envelopes (if applicable) 7.5 Blank SAE forms 7.6 Correspondence Eight Subject Logs and Consent Forms 8.1 Subject Screening and Enrolment Log, Identification Code List 8.2 Signed Informed Consent Forms Nine Equipment (if applicable) 9.1 Calibration Certificates 9.2 Related Correspondence Ten Pharmacy (to be kept in pharmacy department whilst study is ongoing if using Pharmacy Services) This section may not always be applicable 10.1 Delegation of Authority and Signature Form 10.2 Pharmacy Agreement 10.3 Cheque request forms/invoices 10.4 Documentation of shipment 10.5 Sample of labelling 10.6 Instructions for handling of study medication 10.7 Notification of unblinding 10.8 Retrieval of code-break envelopes 10.9 Drug accountability 10.10 Pharmacy correspondence Eleven Local Laboratory (where a Central Laboratory is not used) 11.1 Laboratory Agreement 11.2 Normal Ranges 11.3 Accreditation