INCLUSION OF PATIENTS Sample Clauses
The 'Inclusion of Patients' clause defines the criteria and process for selecting individuals who are eligible to participate in a clinical study or trial. It typically outlines specific requirements such as age range, medical condition, or other relevant characteristics that participants must meet to be enrolled. By clearly establishing who can be included, this clause ensures that the study population is appropriate for the research objectives and helps maintain the integrity and validity of the study results.
INCLUSION OF PATIENTS. The Sponsor reserves the right to interrupt the inclusion of patients in the Trial under any of the following circumstances: If the Principal Investigator does not include, without justification accepted by the Parties, the agreed number of patients during the designated time period. If the total number of patients that must be included in the Trial by the different researchers participating in the Trial is reached when a multicentre Trial is involved. Patients may not be recruited after the end of the trial inclusion period, unless the ECRm approves the corresponding modification of the Protocol.
INCLUSION OF PATIENTS. The Sponsor reserves the right to interrupt the inclusion of patients in the Study under any of the following circumstances: If the Principal Investigator does not include, without justification accepted by the Parties, the agreed number of patients during the designated time period. If the total number of patients that must be included in the Study by the different researchers participating in the Study is reached when a multicentre Study is involved. Patients may not be recruited after the end of the Study inclusion period, unless the ECRm approves the corresponding modification of the Protocol. Likewise, patients included in the Study may be eligible to participate in an internal research project of the Oncology / Medical Hematology / Radiation Oncology Department of the HUVH, approved by the ECRm, provided that it does not interfere with the performance and evaluation of the Study that is the subject of this Contract.
INCLUSION OF PATIENTS. The Sponsor reserves the right to interrupt the inclusion of patients in the Trial under any of the following circumstances: If the Principal Investigator does not include, without justification accepted by the Parties, the agreed number of patients during the designated time period. If the total number of patients that must be included in the Trial by the different researchers participating in the Trial is reached when a multicentre Trial is involved. Patients may not be recruited after the end of the trial inclusion period, unless the ECRm approves the corresponding modification of the Protocol. Likewise, the patients included in the Trial may be susceptible to participate in an internal research project of the Oncology / Medical Hematology / Radiation Oncology Department of the HUVH, approved by the ECRm, provided that it does not interfere with the performance and evaluation of the Trial that is the object of this Contract.
INCLUSION OF PATIENTS. The Sponsor reserves the right to discontinue inclusion of patients in any of the following cases: If the principal investigator does not include the agreed-upon number of patients during the designated time frame. When, in the case of a multicenter study, the total number of patients to be included in the study has already been reached by other investigators. In either case, the Sponsor agrees to notify the CREC and the principal investigator.
INCLUSION OF PATIENTS. The sponsor reserves the right to stop further inclusion of patients in any of the following circumstances: Should the principal investigator, without justification acceptable to both parties, fail to include the number of patients agreed to during the specified recruitment period. In the case of multi-centre trials, should the total number of patients to be included in the trial by the different participating investigators have been reached. Unless the enrolment period has been extended by written agreement of the parties, or the trial discontinued for justified reasons or by mutual agreement, the inclusion of the patients shall have been completed by the date of expiry to the trial.
INCLUSION OF PATIENTS. (Remove redundant alternative / text, include necessary text) New patients may be included in Compassionate Use Program (CUP) / Compassionate Use Named Patient (CUNP) until the pharmaceutical drug is granted MA. New patients may be included in Compassionate Use Program (CUP) / Compassionate Use Named Patient (CUNP) [x] months from the Framework Agreement entry into force. The Parties may agree to extend the period of inclusion beyond this. Patients can be included until marketed packages is available for purchase in Norway. Such inclusion after marketing authorization, but before available marketed packaging, must be done by agreement with the supplier. “Marketed packaging available for purchase” means the packaging, which has Norwegian marketing authorization and list price, is available for order at the pharmaceutical wholesaler(s). Available for purchase is independent of government funding. Regardless of the first paragraph, the Supplier has the right to close inclusion of new patients with effect from two (2) months after written notice has been sent (from the date notice is sent). The duration of the inclusion period, even upon notice to close inclusion, cannot be less than three (3) months.
INCLUSION OF PATIENTS. (Remove redundant alternative / text, include necessary text) New patients may be included in Compassionate Use Program (CUP) / Compassionate Use Named Patient (CUNP) until the pharmaceutical drug is granted MA. New patients may be included in Compassionate Use Program (CUP) / Compassionate Use Named Patient (CUNP) [x] months from the Framework Agreement entry into force. The Parties may agree to extend the period of inclusion beyond this. Regardless of the first paragraph, the Supplier has the right to close inclusion of new patients with effect from two (2) months after written notice has been sent (from the date notice is sent). The duration of the inclusion period, even upon notice to close inclusion, cannot be less than three (3) months.
INCLUSION OF PATIENTS. The Trial Sponsor reserves the right to interrupt the inclusion of patients under any of the following circumstances: If the Principal Investigator does not include, without justification accepted by the Parties, the agreed number of patients during the designated time period. If the total number of patients that must be included in the Trial by the different researchers participating in the Trial is reached when a multicentre Trial is involved. On the date when the Trial ends, the inclusion of the number of patients anticipated must have occurred, unless the Parties agree in writing to extend the time period for inclusion of patients. Despite the foregoing, the patients included in the Trial may be able to participate in internal research of the HUVH Medical Oncology service, approved by the ECRm, provided that this does not interfere with the performance and evaluation of the Trial that is the subject matter of the Contract.