Common use of Study Data Clause in Contracts

Study Data. The Institution and Investigator agree to record all Study Data (including, without limitation, CRFs or eCRF’s, laboratory work sheets, slides and reports) generated as a result of conducting the Study (collectively, the “Study Data”) in a timely, accurate, complete, and legible manner in the form described in the Protocol and in compliance with all applicable laws and regulations. The Investigator shall take reasonable and customary precautions, including periodic backup of computer files, to prevent the loss or alteration of any Study Data. Investigator shall ensure that all information entered into the CRFs (or eCRFs) shall reflect the Trial Subject’s true condition. The Investigator shall review all CRFs (or eCRFs) and check the data against all pertinent information in the Trial Subjects clinical records for accuracy and completeness of information, legibility of entries, correct any erroneous data, record use of concomitant drugs, report Adverse Events, concurrent illnesses and document reasons for any missing visits or examinations. The Institution and Investigator shall assist Pharm- Olam, Sponsor and/or Pharm-Olam’s or Sponsor’s representatives and Study monitors upon their request, in promptly resolving any discrepancies or errors contained in the CRFs (or eCRFs) and in performing random audits on Trial Subjects’ records, laboratory reports, or other raw data sources underlying the data recorded on the CRFs (or eCRFs). During the Study, Pharm-Olam, or its representatives shall have the right upon prior notice and during normal business hours to review and verify and at times, to the extent allowed by law, copy (only pseudonymized or anonymized data), all Study Data including, without limitation, original reports of laboratory tests and examination findings, and all other notes, charts, reports, electronic health records or memoranda relating to Trial Subjects enrolled in the Study. In addition, during the Study and for a reasonable period (at least 5 years) following the completion of the Study, Pharm-Olam, Sponsor or their representatives shall have the right to review Trial Subject medical records or certified copies of any electronic health records relating to the Study only for auditing purposes according to applicable law. No later than ten (10) days after the completion or termination of the Study,

Study Data. The Institution and Investigator agree to record all Study Data (including, without limitation, CRFs or eCRF’s, laboratory work sheets, slides and reports) generated as a result of conducting the Study (collectively, the “Study Data”) in a timely, accurate, complete, and legible manner in the form described in the Protocol and in compliance with all applicable laws and regulations. The Investigator shall take reasonable and customary precautions, including periodic backup of computer files, to prevent the loss or alteration of any Study Data. Investigator shall ensure that all information entered into the CRFs (or eCRFs) shall reflect the Trial Subject’s true condition. The Investigator shall review all CRFs (or eCRFs) and check the data against all pertinent information in the Trial Subjects clinical records for accuracy and completeness of information, legibility of entries, correct any erroneous data, record use of concomitant drugs, report Adverse Events, concurrent illnesses and document reasons for any missing visits or examinations. The Institution and Investigator shall assist Pharm- Olam, Sponsor and/or Pharm-Olam’s or Sponsor’s representatives and Study monitors upon their request, in promptly resolving any discrepancies or errors contained in the CRFs (or eCRFs) and in performing random audits on Trial Subjects’ records, laboratory reports, or other raw data sources underlying the data recorded on the CRFs (or eCRFs). During the Study, Pharm-Olam, or its representatives shall have the right upon prior notice and during normal business hours to review and verify and at times, to the extent allowed by law, copy (only pseudonymized or anonymized data), all Study Data including, without limitation, original reports of laboratory tests and examination findings, and all other notes, charts, reports, electronic health records or memoranda relating to Trial Subjects enrolled in the Study. In addition, during the Study and for a reasonable period (at least 5 years) following the completion of the Study, Pharm-Olam, Sponsor or their representatives shall have the right to review Trial Subject medical records or certified copies of any electronic health records relating to the Study only for auditing purposes according to applicable law. No later than ten (10) days after the completion or termination of the Study,and

Study Data. The Institution and Investigator agree to record all Study Data (including, without limitation, CRFs or eCRF’s, laboratory work sheets, slides and reports) generated as a result of conducting the Study (collectively, the “Study Data”) in a timely, accurate, complete, and legible manner in the form described in the Protocol and in compliance with all applicable laws and regulations. The Investigator shall take reasonable and customary precautions, including periodic backup of computer files, to prevent the loss or alteration of any Study Data. Investigator shall ensure that all information entered into the CRFs (or eCRFs) shall reflect the Trial Subject’s true condition. The Investigator shall review all CRFs (or eCRFs) and check the data against all pertinent information in the Trial Subjects clinical records for accuracy and completeness of information, legibility of entries, correct any erroneous data, record use of concomitant drugs, report Adverse Events, concurrent illnesses and document reasons for any missing visits or examinations. The Institution and Investigator shall assist Pharm- Olam, Sponsor and/or Pharm-Olam’s or Sponsor’s representatives and Study monitors upon their request, in promptly resolving any discrepancies or errors contained in the CRFs (or eCRFs) and in performing random audits on Trial Subjects’ records, laboratory reports, or other raw data sources underlying the data recorded on the CRFs (or eCRFs). During the Study, Pharm-Olam, or its representatives shall have the right upon prior notice and during normal business hours to review and verify and at times, to the extent allowed by law, copy (only pseudonymized or anonymized data), all Study Data including, without limitation, original reports of laboratory tests and examination findings, and all other notes, charts, reports, electronic health records or memoranda relating to Trial Subjects enrolled in the Study. In addition, during the Study and for a reasonable period (at least 5 years) following the completion of the Study, Pharm-Olam, Sponsor or their representatives shall have the right to review Trial Subject medical records or certified copies of any electronic health records relating to the Study only for auditing purposes according to applicable law. No later than ten (10) days after the completion or termination of the Study,or