Collection, Storage and Destruction. Institution shall ensure the prompt, complete, and accurate collection, recording and classification of the Medical Records and Study Data. Institution shall: maintain and store Medical Records and Study Data in a secure manner with physical and electronic access restrictions, as applicable and environmental controls appropriate to the applicable data type and in accordance with applicable laws, regulations and industry standards; and protect the Medical Records and Study Data from unauthorized use, access, duplication, and disclosure. If directed by Sponsor or Quintiles, Institution will submit Study Data using the electronic system provided by Sponsor or Quintiles or their designated representative and in accordance with Sponsor’s instructions for electronic data entry. Investigator shall prevent unauthorized access to the Study Data by maintaining physical security of the electronic system and ensuring that Study Staff maintain the confidentiality of their passwords. Institution agrees to collect all Study Data in Medical Records prior to entering it into the CRF. Investigator shall ensure the prompt submission of CRFs; and take measures to prevent accidental or premature destruction or damage of these documents. Neither Institution nor Investigator shall destroy or permit the destruction of any Medical Records or Study Data without prior written notification to the Sponsor. The Institution will keep all Medical Records and Study Data as well as any documentation related to study subjects for 15 years after completing the Study. After these 15 years, Institution may agree with the Sponsor to continue to store Medical Records and Study Data, at the Sponsor’s expense, for a period agreed in writing with the Sponsor after retention is no longer required by any applicable law or regulation. In case of termination of Investigator employment relationship, the responsibility for maintaining Medical Records and Study Data shall be determined in accordance with applicable regulations but Institution will not in any case be relieved of its obligations under this Agreement for maintaining the Medical Records and Study Data.
Appears in 1 contract
Sources: Clinical Trial Agreement
Collection, Storage and Destruction. Institution shall ensure the prompt, complete, and accurate collection, recording and classification of the Medical Records and Study Data. Institution shall: maintain and store Medical Records and Study Data in a secure manner with physical and electronic access restrictions, as applicable and environmental controls appropriate to the applicable data type and in accordance with applicable laws, regulations and industry standards; and protect the Medical Records and Study Data from unauthorized use, access, duplication, and disclosure. If directed by Sponsor or QuintilesIQVIA, Institution will submit Study Data using the electronic system provided by Sponsor or Quintiles IQVIA or their designated representative and in accordance with Sponsor’s instructions for electronic data entry. Investigator Institution shall prevent unauthorized access to the Study Data by maintaining physical security of the electronic system and ensuring that Study Staff maintain the confidentiality of their passwords. Institution agrees to collect all Study Data in Medical Records prior to entering it into the CRF. Investigator Institution shall ensure the prompt submission of CRFs; and take all reasonable measures to prevent accidental or premature destruction or damage of these documents. Neither Institution nor Investigator shall destroy or permit the destruction of any Medical Records or Study Data without prior written notification to the Sponsor. The Institution will keep all Medical Records and Study Data as well as any documentation related to study subjects for 15 25 years after completing the Study. After these 15 years, Institution may agree with the Sponsor to continue to store Medical Records and Study Data, at the Sponsor’s expense, for a period agreed in writing with the Sponsor after retention is no longer required by any applicable law or regulation. In case of termination of Investigator employment relationship, the responsibility for maintaining Medical Records and Study Data shall be determined in accordance with applicable regulations but Institution will not in any case be relieved of its obligations under this Agreement for maintaining the Medical Records and Study Data.
Appears in 1 contract
Sources: Clinical Trial Agreement
Collection, Storage and Destruction. Institution shall ensure the prompt, complete, and accurate collection, recording and classification of the Medical Records and Study Data. Institution shall: maintain and store Medical Records and Study Data in a secure manner with physical and electronic access restrictions, as applicable and environmental controls appropriate to the applicable data type and in accordance with applicable laws, regulations and industry standards; and protect the Medical Records and Study Data from unauthorized use, access, duplication, and disclosure. If directed by Sponsor or Quintiles, Institution will submit Study Data using the electronic system provided by Sponsor or Quintiles or their designated representative and in accordance with Sponsor’s instructions for electronic data entry. Investigator Institution shall prevent unauthorized access to the Study Data by maintaining physical security of the electronic system and ensuring that Study Staff maintain the confidentiality of their passwords. Institution agrees to collect all Study Data in Medical Records prior to entering it into the CRF. Investigator Institution shall ensure the prompt submission of CRFs; and take measures to prevent accidental or premature destruction or damage of these documents. Neither Institution nor Investigator shall destroy or permit the destruction of any Medical Records or Study Data without prior written notification to the Sponsor. The Institution will keep all Medical Records and Study Data as well as any documentation related to study subjects for 15 years after completing the Study. After these 15 years, Institution may agree with the Sponsor to continue to store Medical Records and Study Data, at the Sponsor’s expense, for a period agreed in writing with the Sponsor after retention is no longer required by any applicable law or regulation. In case of termination of Investigator employment relationship, the responsibility for maintaining Medical Records and Study Data shall be determined in accordance with applicable regulations but Institution will not in any case be relieved of its obligations under this Agreement for maintaining the Medical Records and Study Data.
Appears in 1 contract
Sources: Clinical Trial Agreement
Collection, Storage and Destruction. Institution shall ensure the prompt, complete, and accurate collection, recording and classification of the Medical Records and Study Data. Institution shall: maintain and store Medical Records and Study Data in a secure manner with physical and electronic access restrictions, as applicable and environmental controls appropriate to the applicable data type and in accordance with applicable laws, regulations and industry standards; and protect the Medical Records and Study Data from unauthorized use, access, duplication, and disclosure. If directed by Sponsor or Quintiles, Institution will submit Study Data using the electronic system provided by Sponsor or Quintiles or their designated representative and in accordance with Sponsor’s instructions for electronic data entry. Investigator Institution shall prevent unauthorized access to the Study Data by maintaining physical security of the electronic system and ensuring that Study Staff maintain the confidentiality of their passwords. Institution agrees to collect all Study Data in Medical Records prior to entering it into the CRF. Investigator Institution shall ensure the prompt submission of CRFs; and take measures to prevent accidental or premature destruction or damage of these documents. Neither Institution nor Investigator shall destroy or permit the destruction of any Medical Records or Study Data without obtaining prior written notification to consent from the Sponsor. The Institution will keep all Medical Records and Study Data as well as any documentation related to study subjects for 15 years after completing the Study. After these 15 years, Institution may agree with the Sponsor to continue to store Medical Records and Study Data, at the Sponsor’s expense, for a period agreed in writing with the Sponsor after retention is no longer required by any applicable law or regulation. In case of termination of Investigator employment relationship, the responsibility for maintaining Medical Records and Study Data shall be determined in accordance with applicable regulations but Institution will not in any case be relieved of its obligations under this Agreement for maintaining the Medical Records and Study Data.
Appears in 1 contract
Sources: Clinical Trial Agreement