Common use of Completion of Source Documents and Case Report Forms Clause in Contracts

Completion of Source Documents and Case Report Forms. The nature and location of all source documents will be identified to ensure that original data required to complete the CRFs exist and are accessible for verification by the site monitor, and all discrepancies shall be appropriately documented via the query resolution process. Site monitors are appointed by the study sponsor and are independent of study site staff. If electronic records are maintained, the method of verification must be determined in advance of starting the study. At a minimum, source documents include the following information for each subject: • Subject identification (name, sex, race/ethnicity) • Documentation of subject eligibility • Date of informed consent • Dates of visits • Documentation that protocol specific procedures were performed • Results of study parameters, as required by the protocol • IP accountability records • Documentation of AEs and other safety parameters (if applicable) • Records regarding medical histories and the use of concomitant therapies prior to and during the study • Date of study completion and reason for early discontinuation, if applicable It is required that the author of an entry in the source documents be identifiable. Direct access to source documentation (medical records) must be allowed for the purpose of verifying that the data recorded on the CRF are consistent with the original source data. Only designated individuals at the site will complete the CRFs. The CRFs must be completed at regular intervals following the clinical study visit schedule. It is expected that all data reported have corresponding entries in the source documents. The principal investigator is responsible for reviewing and certifying that the CRFs are accurate and complete. The only subject identifiers recorded on the CRFs will be subject number, and subject demographic information.

Completion of Source Documents and Case Report Forms. The nature and location of all source documents will be identified to ensure that original data required to complete the CRFs exist and are accessible for verification by the site monitor, and all discrepancies shall be appropriately documented via the query resolution process. Site monitors are appointed by the study sponsor Study Sponsor and are independent of study site staff. If electronic records are maintained, the method of verification must be determined in advance of starting the study. At a minimum, source documents include the following information for each subject: • Subject identification (name, sex, race/ethnicity) • Documentation of subject eligibility • Date of informed consent • Dates of visits • Documentation that protocol specific procedures were performed • Results of study parameters, as required by the protocol • IP accountability records • Documentation of AEs and other safety parameters (if applicable) • Records regarding medical histories and the use of concomitant therapies prior to and during the study • Date of study completion and reason for early discontinuation, if applicable It is required that the author of an entry in the source documents be identifiable. Direct access to source documentation (medical records) must be allowed for the purpose of verifying that the data recorded on the CRF are consistent with the original source data. Only designated individuals at the site will complete the CRFs. The CRFs must be completed at regular intervals following the clinical study visit schedule. It is expected that all data reported have corresponding entries in the source documents. The principal investigator Principal Investigator is responsible for reviewing and certifying that the CRFs are accurate and complete. The only subject identifiers recorded on the CRFs will be subject number, and subject demographic information.

Completion of Source Documents and Case Report Forms. The nature and location of all source documents will be identified to ensure that original data required to complete the CRFs eCRFs exist and are accessible for verification by the site monitor, and all discrepancies shall be appropriately documented via the query resolution process. Site Study monitors are appointed by the study sponsor Study Sponsor and are independent of study site staff. If electronic records are maintained, the method of verification must be determined in advance of starting the study. At a minimum, source documents should include the following information for each subject: • Subject identification (name, sex, race/ethnicity) • Documentation of subject eligibility • Date of informed consent • Dates of visits • Documentation that protocol specific procedures were performed • Results of study parameters, as required by the protocol • IP accountability records • Documentation of AEs and other safety parameters (if applicable) • Records regarding medical histories and the use of concomitant therapies prior to and during the study • Date of study completion and reason for early discontinuation, if applicable It is required that the author of an entry in the source documents be identifiable. Direct access to source documentation (medical records) must be allowed for the purpose of verifying that the data recorded on the CRF eCRF are consistent with the original source data. Only designated individuals at the site will may complete the CRFseCRFs. The CRFs must eCRFs will be completed submitted at regular intervals following the clinical study visit schedule. It is expected that all data reported will have corresponding entries in the source documents. The principal investigator Principal Investigator is responsible for reviewing and certifying that the CRFs eCRFs are accurate and complete. The only subject identifiers recorded on the CRFs eCRFs will be subject number, and subject demographic information.

Completion of Source Documents and Case Report Forms. The nature and location of all source documents will be identified to ensure that original data required to complete the CRFs eCRFs exist and are accessible for verification by the site monitor, and all discrepancies shall be appropriately documented via the query resolution process. Site Study monitors are appointed by the study sponsor Study Sponsor and are independent of study site staff. If electronic records are maintained, the method of verification must be determined in advance of starting the study. At a minimum, source documents should include the following information for each subject: subject:‌‌ • Subject identification (name, sex, race/ethnicity) • Documentation of subject eligibility • Date of informed consent • Dates of visits • Documentation that protocol specific procedures were performed • Results of study parameters, as required by the protocol • IP accountability records • Documentation of AEs and other safety parameters (if applicable) • Records regarding medical histories and the use of concomitant therapies prior to and during the study • Date of study completion and reason for early discontinuation, if applicable It is required that the author of an entry in the source documents be identifiable. Direct access to source documentation (medical records) must be allowed for the purpose of verifying that the data recorded on the CRF eCRF are consistent with the original source data. Only designated individuals at the site will may complete the CRFseCRFs. The CRFs must eCRFs will be completed submitted at regular intervals following the clinical study visit schedule. It is expected that all data reported will have corresponding entries in the source documents. The principal investigator Principal Investigator is responsible for reviewing and certifying that the CRFs eCRFs are accurate and complete. The only subject identifiers recorded on the CRFs eCRFs will be subject number, and subject demographic information.

Completion of Source Documents and Case Report Forms. The nature and location of all source documents will be identified to ensure that original data required to complete the CRFs eCRFs exist and are accessible for verification by the site monitor, and all discrepancies shall be appropriately documented via the query resolution process. Site Study monitors are appointed by the study sponsor Study Sponsor and are independent of study site staff. If electronic records are maintained, the method of verification must be determined in advance of starting the study. At a minimum, source documents should include the following information for each subject: • Subject identification (name, sex, race/ethnicity) • Documentation of subject eligibility • Date of informed consent • Dates of visits • Documentation that protocol specific procedures were performed • Results of study parameters, as required by the protocol • IP accountability records • Documentation of AEs and other safety parameters (if applicable) • Records regarding medical histories and the use of concomitant therapies prior to and during the study • Date of study completion and reason for early discontinuation, if applicable It is required that the author of an entry in the source documents be identifiable. Direct access to source documentation (medical records) must be allowed for the purpose of verifying that the data recorded on the CRF eCRF are consistent with the original source data. Only designated individuals at the site will may complete the CRFseCRFs. The CRFs must eCRFs will be completed submitted at regular intervals following the clinical study visit schedule. It is expected that all data reported will have corresponding entries in the source documents. The principal investigator Principal Investigator is responsible for reviewing and certifying that the CRFs eCRFs are accurate and complete. The only subject identifiers recorded on the CRFs eCRFs will be subject number, number and subject demographic information.

Completion of Source Documents and Case Report Forms. The nature and location of all source documents will be identified to ensure that original data required to complete the CRFs exist and are accessible for verification by the site monitor, and all discrepancies shall be appropriately documented via the query resolution process. Site monitors are appointed by the study sponsor Study Sponsor and are independent of study site staff. If electronic records are maintained, the method of verification must be determined in advance of starting the study. At a minimum, source documents include the following information for each subject: •  Subject identification (name, sex, race/ethnicity) •  Documentation of subject eligibility •  Date of informed consent •  Dates of visits •  Documentation that protocol specific procedures were performed •  Results of study parameters, as required by the protocol •  IP accountability records •  Documentation of AEs and other safety parameters (if applicable) •  Records regarding medical histories and the use of concomitant therapies prior to and during the study •  Date of study completion and reason for early discontinuation, if applicable It is required that the author of an entry in the source documents be identifiable. Direct access to source documentation (medical records) must be allowed for the purpose of verifying that the data recorded on the CRF are consistent with the original source data. Only designated individuals at the site will complete the CRFs. The CRFs must be completed at regular intervals following the clinical study visit schedule. It is expected that all data reported have corresponding entries in the source documents. The principal investigator Principal Investigator is responsible for reviewing and certifying that the CRFs are accurate and complete. The only subject identifiers recorded on the CRFs will be subject number, number and subject demographic information.

Completion of Source Documents and Case Report Forms. The nature and location of all source documents will be identified to ensure that original data required to complete the CRFs exist and are accessible for verification by the site monitor, and all discrepancies shall be appropriately documented via the query resolution process. Site monitors are appointed by the study sponsor Study Sponsor and are independent of study site staff. If electronic records are maintained, the method of verification must be determined in advance of starting the study. At a minimum, source documents include the following information for each subject: •  Subject identification (name, sex, race/ethnicity) •  Documentation of subject eligibility •  Date of informed consent •  Dates of visits •  Documentation that protocol specific procedures were performed •  Results of study parameters, as required by the protocol •  IP accountability records •  Documentation of AEs and other safety parameters (if applicable) •  Records regarding medical histories and the use of concomitant therapies prior to and during the study •  Date of study completion and reason for early discontinuation, if applicable It is required that the author of an entry in the source documents be identifiable. Direct access to source documentation (medical records) must be allowed for the purpose of verifying that the data recorded on the CRF are consistent with the original source data. Only designated individuals at the site will complete the CRFs. The CRFs must be completed at regular intervals following the clinical study visit schedule. It is expected that all data reported have corresponding entries in the source documents. The principal investigator Principal Investigator is responsible for reviewing and certifying that the CRFs are accurate and complete. The only subject identifiers recorded on the CRFs will be subject number, and subject demographic information.

Completion of Source Documents and Case Report Forms. The nature and location of all source documents will be identified to ensure that original data required to complete the CRFs exist and are accessible for verification by the site monitor, and all discrepancies shall be appropriately documented via the query resolution process. Site monitors are appointed by the study sponsor Study Sponsor and are independent of study site staff. If electronic records are maintained, the method of verification must be determined in advance of starting the study. At a minimum, source documents include the following information for each subject: • Subject identification (name, sex, race/ethnicity) • Documentation of subject eligibility • Date of informed consent • Dates of visits • Documentation that protocol specific procedures were performed • Results of study parameters, as required by the protocol • IP accountability records • Documentation of AEs and other safety parameters (if applicable) • Records regarding medical histories and the use of concomitant therapies prior to and during the study • Date of study completion and reason for early discontinuation, if applicable It is required that the author of an entry in the source documents be identifiable. Direct access to source documentation (medical records) must be allowed for the purpose of verifying that the data recorded on the CRF are consistent with the original source data. Only designated individuals at the site will complete the CRFs. The CRFs must be completed at regular intervals following the clinical study visit schedule. It is expected that all data reported have corresponding entries in the source documents. The principal investigator Principal Investigator is responsible for reviewing and certifying that the CRFs are accurate and complete. The only subject identifiers recorded on the CRFs will be subject number, number and subject demographic information.

Completion of Source Documents and Case Report Forms. The nature and location of all source documents will be identified to ensure that original data required to complete the CRFs exist and are accessible for verification by the site monitor, and all discrepancies shall be appropriately documented via the query resolution process. Site monitors are appointed by the study sponsor and are independent of study site staff. If electronic records are maintained, the method of verification must be determined in advance of starting the study. At a minimum, source documents include the following information for each subject: • Subject identification (name, sex, race/ethnicity) • Documentation of subject eligibility • Date of informed consent • Dates of visits • Documentation that protocol specific procedures were performed • Results of study parameters, as required by the protocol • IP accountability records • Documentation of AEs and other safety parameters (if applicable) • Records regarding medical histories and the use of concomitant therapies prior to and during the study • Date of study completion and reason for early discontinuation, if applicable It is required that the author of an entry in the source documents be identifiable. Direct access to source documentation (medical records) must be allowed for the purpose of verifying that the data recorded on the CRF are consistent with the original source data. Only designated individuals at the site will complete the CRFs. The CRFs must be completed at regular intervals following the clinical study visit schedule. It is expected that all data reported have corresponding entries in the source documents. The principal investigator is responsible for reviewing and certifying that the CRFs are accurate and complete. The only subject identifiers recorded on the CRFs will be subject number, and subject demographic information.

Completion of Source Documents and Case Report Forms. The nature and location of all source documents will be identified to ensure that original data required to complete the CRFs eCRFs exist and are accessible for verification by the site monitor, and all discrepancies shall be appropriately documented via the query resolution process. Site Study monitors are appointed by the study sponsor Study Sponsor and are independent of study site staff. If electronic records are maintained, the method of verification must be determined in advance of starting the study. At a minimum, source documents should include the following information for each subject: • subject:‌‌  Subject identification (name, sex, race/ethnicity) •  Documentation of subject eligibility •  Date of informed consent •  Dates of visits •  Documentation that protocol specific procedures were performed •  Results of study parameters, as required by the protocol •  IP accountability records •  Documentation of AEs and other safety parameters (if applicable) •  Records regarding medical histories and the use of concomitant therapies prior to and during the study •  Date of study completion and reason for early discontinuation, if applicable It is required that the author of an entry in the source documents be identifiable. Direct access to source documentation (medical records) must be allowed for the purpose of verifying that the data recorded on the CRF eCRF are consistent with the original source data. Only designated individuals at the site will may complete the CRFseCRFs. The CRFs must eCRFs will be completed submitted at regular intervals following the clinical study visit schedule. It is expected that all data reported will have corresponding entries in the source documents. The principal investigator Principal Investigator is responsible for reviewing and certifying that the CRFs eCRFs are accurate and complete. The only subject identifiers recorded on the CRFs eCRFs will be subject number, and subject demographic information.

Completion of Source Documents and Case Report Forms. The nature and location of all source documents will be identified to ensure that original data required to complete the CRFs exist and are accessible for verification by the site monitor, and all discrepancies shall be appropriately documented via the query resolution process. Site monitors are appointed by the study sponsor Study Sponsor and are independent of study site staff. If electronic records are maintained, the method of verification must be determined in advance of starting the study. At a minimum, source documents include the following information for each subject: • Subject identification (name, sex, race/ethnicity) • Documentation of subject eligibility • Date of informed consent • Dates of visits • Documentation that protocol specific procedures were performed • Results of study parameters, as required by the protocol • IP accountability records • Documentation of AEs and other safety parameters (if applicable) • Records regarding medical histories and the use of concomitant therapies prior to and during the study • Date of study completion and reason for early discontinuation, if applicable It is required that the author of an entry in the source documents be identifiable. Direct access to source documentation (medical records) must be allowed for the purpose of verifying that the data recorded on the CRF are consistent with the original source data. Only designated individuals at the site will complete the CRFs. The CRFs must be completed at regular intervals following the clinical study visit schedule. It is expected that all data reported have corresponding entries in the source documents. The principal investigator Principal Investigator is responsible for reviewing and certifying that the CRFs are accurate and complete. The only subject identifiers recorded on the CRFs will be subject number, and subject demographic information.information.‌‌‌

Completion of Source Documents and Case Report Forms. The nature and location of all source documents will be identified to ensure that original data required to complete the CRFs eCRFs exist and are accessible for verification by the site monitor, and all discrepancies shall be appropriately documented via the query resolution process. Site Study monitors are appointed by the study sponsor Study Sponsor and are independent of study site staff. If electronic records are maintained, the method of verification must be determined in advance of starting the study. At a minimum, source documents should include the following information for each subject: • Subject identification (name, sex, race/ethnicity) • Documentation of subject eligibility • Date of informed consent • Dates of visits • Documentation that protocol specific procedures were performed • Results of study parameters, as required by the protocol • IP accountability records • Documentation of AEs and other safety parameters (if applicable) • Records regarding medical histories and the use of concomitant therapies prior to and during the study study‌‌ • Date of study completion and reason for early discontinuation, if applicable It is required that the author of an entry in the source documents be identifiable. Direct access to source documentation (medical records) must be allowed for the purpose of verifying that the data recorded on the CRF eCRF are consistent with the original source data. Only designated individuals at the site will may complete the CRFseCRFs. The CRFs must eCRFs will be completed submitted at regular intervals following the clinical study visit schedule. It is expected that all data reported will have corresponding entries in the source documents. The principal investigator Principal Investigator is responsible for reviewing and certifying that the CRFs eCRFs are accurate and complete. The only subject identifiers recorded on the CRFs eCRFs will be subject number, and subject demographic information.

Completion of Source Documents and Case Report Forms. The nature and location of all source documents will be identified to ensure that original data required to complete the CRFs eCRFs exist and are accessible for verification by the site monitor, and all discrepancies shall be appropriately documented via the query resolution process. Site Study monitors are appointed by the study sponsor and are independent of study site staff. If electronic records are maintained, the method of verification must be determined in advance of starting the study. At a minimum, source documents should include the following information for each subject: • Subject identification (name, sex, race/ethnicity) • Documentation of subject eligibility • Date of informed consent • Dates of visits • Documentation that protocol specific procedures were performed • Results of study parameters, as required by the protocol • IP accountability records • Documentation of AEs and other safety parameters (if applicable) • Records regarding medical histories and the use of concomitant therapies prior to and during the study • Date of study completion and reason for early discontinuation, if applicable It is required that the author of an entry in the source documents be identifiable. Direct access to source documentation (medical records) must be allowed for the purpose of verifying that the data recorded on the CRF eCRF are consistent with the original source data. Only designated individuals at the site will may complete the CRFseCRFs. The CRFs must eCRFs will be completed submitted at regular intervals following the clinical study visit schedule. It is expected that all data reported will have corresponding entries in the source documents. The principal investigator is responsible for reviewing and certifying that the CRFs eCRFs are accurate and complete. The only subject identifiers recorded on the CRFs eCRFs will be subject number, number and subject demographic information.

Completion of Source Documents and Case Report Forms. The nature and location of all source documents will be identified to ensure that original data required to complete the CRFs exist and are accessible for verification by the site monitor, and all discrepancies shall be appropriately documented via the query resolution process. Site monitors are appointed by the study sponsor Study Sponsor and are independent of study site staff. If electronic records are maintained, the method of verification must be determined in advance of starting the study. At a minimum, source documents include the following information for each subject: •  Subject identification (name, sex, race/ethnicity) •  Documentation of subject eligibility •  Date of informed consent •  Dates of visits •  Documentation that protocol specific procedures were performed •  Results of study parameters, as required by the protocol •  IP accountability records •  Documentation of AEs and other safety parameters (if applicable) •  Records regarding medical histories and the use of concomitant therapies prior to and during the study •  Date of study completion and reason for early discontinuation, if applicable It is required that the author of an entry in the source documents be identifiable. Direct access to source documentation (medical records) must be allowed for the purpose of verifying that the data recorded on the CRF are consistent with the original source data. Only designated individuals at the site will complete the CRFs. The CRFs must be completed at regular intervals following the clinical study visit schedule. It is expected that all data reported have corresponding entries in the source documents. The principal investigator Principal Investigator is responsible for reviewing and certifying that the CRFs are accurate and complete. The only subject identifiers recorded on the CRFs will be subject number, and subject demographic information.information.‌‌‌