Common use of Case Report Forms and Study Data Clause in Contracts

Case Report Forms and Study Data. a) PSI shall supply (or if electronic, provide access to) the forms to be used and completed by the Investigator to document a Study subject’s participation in the Study (the “Case Report Forms” or “CRFs”). The Investigator shall record all data generated as a result of conducting the Study (the “Study Data”) within 5 business days, in an accurate and complete manner, and shall ensure that the Case Report Forms for each Study subject are duly signed and dated. To the extent the Study requires completion of electronic Case Report Forms, the Institution and the Investigator shall ensure that they have implemented and maintain appropriate computer security sufficient to protect the confidentiality, integrity and availability of such Study Data in accordance with the Applicable Regulatory Requirements. The Investigator shall not grant unauthorized users access to the electronic data capture (EDC) system used in the Study, and in particular, shall not share or disclose his/her username and/or passwords. b) The Institution and the Investigator shall take reasonable and customary precautions to prevent the loss or alteration of any Study Data. a) Hlavní zkoušející v souladu se všemi Platnými regulačními požadavky získá od všech Subjektů hodnocení nebo jejich zástupců řádně podepsaný informovaný souhlas, a to před zahájením účasti subjektu ve studii. b) Hlavní zkoušející bude používat formulář informovaného souhlasu (dále jen „Formulář informovaného souhlasu“) poskytnutý PSI a schválený v souladu se všemi Platnými regulačními požadavky.

Case Report Forms and Study Data. a) PSI shall supply (or if electronic, provide access to) to the forms electronic Case Report Forms to be used and completed by the Investigator to document a Study subject’s participation in the Study (the “Case Report Forms” or “CRFs”). The Investigator shall record all data generated as a result of conducting the Study (the “Study Data”) within 5 business daysin a timely, in an true, correct, accurate and complete mannermanner in source documents as defined by ICH GCP, and shall ensure that the Case Report Forms for each Study subject are duly signed and dated. The Investigator will be responsible for data entry as set out in the Protocol and in accordance with Sponsor’s instructions. b) To the extent the Study requires completion of electronic Case Report Forms, the Institution and the Investigator shall ensure that they have implemented and maintain appropriate computer security sufficient to protect the confidentiality, integrity and availability of such Study Data in accordance with the Applicable Regulatory Requirements. The Investigator shall not grant unauthorized users access to the electronic data capture (EDC) system used in the Study, and in particular, shall not share or disclose his/her username and/or passwords. b) The Institution and the Investigator shall take reasonable and customary precautions to prevent the loss or alteration of any Study Data. a) Hlavní zkoušející v souladu se všemi Platnými regulačními požadavky získá od všech Subjektů hodnocení nebo jejich zástupců řádně podepsaný informovaný souhlassouhlas schválený EC/IRB, a to před zahájením účasti subjektu ve studii. b) Hlavní zkoušející bude používat formulář informovaného souhlasu (dále jen „Formulář informovaného souhlasu“) poskytnutý PSI a schválený v souladu se všemi Platnými regulačními požadavky.

Case Report Forms and Study Data. a) PSI shall supply (or if electronic, provide access to) the forms to be used and completed by the Investigator to document a Study subject’s participation in the Study (the “Case Report Forms” or “CRFs”). The Investigator shall record all data generated as a result of conducting the Study (the “Study Data”) within 5 business daysin a timely, in an accurate and complete manner, and shall ensure that the Case Report Forms for each Study subject are duly signed and dated. To the extent the Study requires completion of electronic Case Report Forms, the Institution and the Investigator shall ensure that they have implemented and maintain appropriate computer security sufficient to protect the confidentiality, integrity and availability of such Study Data in accordance with the Applicable Regulatory Requirements. The Investigator shall not grant unauthorized users access to the electronic data capture (EDC) system used in the Study, and in particular, shall not share or disclose his/her username and/or passwords. b) The Institution and the Investigator shall take reasonable and customary precautions to prevent the loss or alteration of any Study Data.shall a) Hlavní zkoušející v souladu se všemi Platnými regulačními požadavky získá od všech Subjektů hodnocení nebo jejich zástupců řádně iádně podepsaný informovaný souhlas, a to před pied zahájením účasti subjektu ve studii. b) Hlavní zkoušející bude používat formulář formulái informovaného souhlasu (dále jen „Formulář Formuláš informovaného souhlasu“) poskytnutý PSI a schválený v souladu se všemi Platnými regulačními požadavky.

Case Report Forms and Study Data. a) PSI shall supply (or if electronic, provide access to) the forms to be used and completed by the Investigator to document a Study subject’s participation in the Study (the “Case Report Forms” or “CRFs”). The Investigator shall record all data generated as a result of conducting the Study (the “Study Data”) within 5 business daysin a timely, in an accurate and complete manner, and shall ensure that the Case Report Forms for each Study subject are duly signed and dated. To the extent the Study requires completion of electronic Case Report Forms, the Institution and the Investigator shall ensure that they have implemented and maintain appropriate computer security sufficient to protect the confidentiality, integrity and availability of such Study Data in accordance with the Applicable Regulatory Requirements. The Investigator shall not grant unauthorized users access to the electronic data capture (EDC) system used in the Study, and in particular, shall not share or disclose his/her username and/or passwords. b) The Institution and the Investigator shall take reasonable and customary precautions to prevent the loss or alteration of any Study Data. a) Hlavní zkoušející v souladu se všemi Platnými regulačními požadavky získá od všech Subjektů hodnocení nebo jejich zástupců řádně podepsaný informovaný souhlas, a to před zahájením účasti subjektu Subjektu hodnocení ve studiiStudii. b) Hlavní zkoušející bude používat formulář informovaného souhlasu (dále jen „Formulář informovaného souhlasu“) poskytnutý PSI a schválený v souladu se všemi Platnými regulačními požadavky.

Case Report Forms and Study Data. a) PSI shall supply (or if electronic, provide access to) the forms to be used and completed by the Investigator to document a Study subject’s participation in the Study (the “Case Report Forms” or “CRFs”). The Investigator shall record all data generated as a result of conducting the Study (the “Study Data”) within 5 business daysin a timely, in an accurate and complete manner, and shall ensure that the Case Report Forms for each Study subject are duly signed and dated. To the extent the Study requires completion of electronic Case Report Forms, the Institution and the Investigator shall ensure that they have implemented and maintain appropriate computer security sufficient to protect the confidentiality, integrity and availability of such Study Data in accordance with the Applicable Regulatory Requirements. The Investigator shall not grant unauthorized users access to the electronic data capture (EDC) system used in the Study, and in particular, shall not share or disclose his/her username and/or passwords. b) The Institution and the Investigator shall take reasonable and customary precautions to prevent the loss or alteration of any Study Data.disclose a) Hlavní zkoušející v souladu se všemi Platnými regulačními požadavky získá od všech Subjektů hodnocení nebo jejich zástupců řádně iádně podepsaný informovaný souhlas, a to před pied zahájením účasti subjektu ve studii. b) Hlavní zkoušející bude používat formulář formulái informovaného souhlasu (dále jen „Formulář Formuláš informovaného souhlasu“) poskytnutý PSI a schválený v souladu se všemi Platnými regulačními požadavky.