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After completion of the Form E you have to check this form for completeness and correctness by validation. For registration a strict validation is required, you are not allowed to save any data before the validation is without any findings, see 7.4 waiver. However emergency save may be useful in this situation.

If validation is ok you may save the CRF, this does not cause any action. Only after save with signature, that may be delegated to the investigator, randomization will be performed or registration done