ࡱ> IKH bjbjqq E8ee] OOOOOccc8c;QgggBBB$&&&&&&$G!#JOBBBBBJOOgg_BFOgOg$B$rhTg (v<cRu0$4$$O8BBBBBBBJJBBBBBBB$BBBBBBBBB : ANNEX I: DRUGS, MEDICINAL PRODUCTS OR MEDICAL DEVICES This annex need only be completed if relevant to the research. It should be completed when non-prescription medicines or substances are used, e.g. overthecounter medicines, herbal preparations, etc, as well as prescribed medicines or experimental drugs. Title of research: Is the study initiated/sponsored by a pharmaceutical or other industrial company?YES/NODoes the study involve pre-marketing use of a drug/appliance or a new use for a marketed product? If NO please go to question 3YES/NOIf YES: Does the company agree to abide by the guidelines on compensation of the Association of British Pharmaceutical Industry (ABPI) (clinical trials - compensation for medicine-induced injury) in respect of patients? YES/NO(if YES, a written signed statement from the company to this effect without any qualification clause should be attached)In a study on healthy participants does the company agree to abide by the current guidelines of the ABPI for healthy subjects?YES/NO(if YES, a copy of the proposed volunteer contract should be attached)Does the research comply with the requirements of the UK Medicines for Human Use (clinical trials) Regulations 2004? See HYPERLINK "http://www.ct-toolkit.ac.uk/"http://www.ct-toolkit.ac.uk/ YES/NOWhat is the regulatory status of the drug under the Medicines Act 1968 (as amended)? Does the drug or device have a product licence for the purpose for which it is to be used? Is any drug or device being supplied by a company with a clinical trial Exemption certificate or in response to an investigator with a clinical trial Exemption, or doctors and dentists exemption? YES/NO YES/NO If YES, give details:Clinical trial certificate number(attach a copy of the certificate) Clinical trial exemption number(attach a copy of the certificate) Doctors and dentists exemption number(attach a copy of the certificate) Details of the drug or medical device Approved name StrengthDosage and frequencyRouteWho will administer the drug or fit the device? Have arrangements for dispensing drugs/device been agreed? (please give details)      REC Procedures 2002  TIME \@ "dd/MM/yyyy" 09/02/2012 6sw6 8 M N ( / 0      U ^ _ ` a   ! 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