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Study guidance or the COVID-19-Pandemic

02.04.2020

Information in order to treat the patients in the clinical study in the best possible way and in accordance with the protocol.

Dear investigators, dear study teams

the pandemic coronavirus (COVID-19) and the changes in daily life and health services are spreading. This may also affect clinical trials in which patients are being recruited or are undergoing clinical treatment. The protocol and GCP compliant execution of the clinical trial can be made more difficult. For this reason, we, as a sponsor, would like to provide you with some information in this letter in order to treat the patients in the clinical study in the best possible way and in accordance with the protocol.
When making decisions, the first priority is to ensure the safety and well-being of study participants and the integrity of the study data.

Recruitment of new patients

After careful consideration, we have decided that, at this time, patients can continue to be included in our studies if your hospital or practice has the capacity and can assure that

1) patient safety
and
2) the treatment of the patient is feasible according to the protocol at the time of inclusion in the study.
Please note that patients cannot be enrolled in studies if their suitability has not been properly assessed. This means that all inclusion and exclusion criteria must be met and that it must also be possible to carry out the planned tests and to obtain written informed consent. No deviations can be allowed here.

Patient visits

However, due to the current Covid-19 situation, several hospitals or practices have restricted access for patients who do not require urgent medical treatment.

Visits to patients already included should be carried out as provided in the protocol, if possible. However, information on survival status, disease status, further cancer surgeries and therapies, and adverse events may also be obtained by telephone or, if justifiable, at a later date. In the event that the study patient cannot reach the site to have tests performed that are necessary for safety (e.g. blood picture, liver function tests, X-rays, ECG, etc.), it is acceptable that laboratory testing, imaging or other diagnostic tests be performed in another, local laboratory or practice. However, these laboratories or practices must be authorized or certified to perform such tests on a routine basis.
The investigator must decide on the respective procedure depending on the situation and document it in the patient file so that the decision and, if it is a deviation from the protocol, the deviation is traceable.
Perform all other examinations as soon as possible when patients are allowed to return to the hospital.

Protocol deviations

Since all protocol deviations must be evaluated at a later time, we ask for appropriate documentation with the reference "COVID-19" in the patient file. If there are special requirements in your clinic or practice, please file these in the investigator site file (“ISF”).

Study medication

As of today, there are no restrictions regarding the provision of study medication. For patients with oral study therapy, it should be checked whether study medication can be delivered to the patients by other means if a visit to the clinic is not possible. Please also document this accordingly.

Biomaterial

Shipment of samples for central pathology

At this time, we are not aware of any postal restrictions that could affect the transport of FFPE samples in screening. Please make sure that the samples are sent in time to avoid possible delays in delivery. We currently do not recommend sending the samples by courier, as the shipment box are usually not delivered to the intended recipient and therefore cannot be processed in a timely manner. If for any reason (e.g. courier is not allowed to pick up samples and transport them to the central laboratory) the analysis of samples in the central laboratory should not be possible, please contact your responsible monitor or the project management. Please also note that samples from a corona infected patient must not be sent to the central laboratory.

Blood samples and other samples

Please do not collect blood or stool samples for the biobank from patients who are infected with COVID-19 or if there is a reasonable suspicion. Should you subsequently become aware of the infection of a patient from whom samples have already been taken, please destroy them properly.
There are currently no restrictions on the collection of freezing samples.

Kit supply

Kit supply is currently guaranteed, please refrain from ordering excessive quantities of kits in stock. Should it happen that no kit is available at the site due to delays in delivery or similar, please use an EDTA tube available at your site for plasma samples. Unfortunately, there is no alternative medium for the stool samples. Please remember to label the samples correctly, even if no GBG label is available.

General information

If you have questions about patients undergoing screening, therapy or follow-up, please contact your monitor or project management.
As the situation with regard to the COVID-19 pandemic changes daily, we will continue to monitor the situation closely and, if necessary, inform you promptly about further necessary measures and changes.

Please also note the EMA guideline "Guidance on the Management of Clinical Trials during the COVID 19 (Coronavirus) pandemic". You can find it under:
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf

If you have any questions, please do not hesitate to contact us.

We thank you all for your continued support in these difficult times!
With best regards,
Your GBG Team

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